Efficacy and Safety of Trabeculectomy in Pakistani Patients with Mitomycin C delivered via Sub Tenon Injection versus Conventional Soaked Sponges | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Efficacy and Safety of Trabeculectomy in Pakistani Patients with Mitomycin C delivered via Sub Tenon Injection versus Conventional Soaked Sponges Hina Qazi, Zehra Abdul, Rida Ayub, Karim Damji, Salim Mahar This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-4212897/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Purpose: Trabeculectomy with Mitomycin C (MMC) is a frequent choice for surgical intervention to effectively control intraocular pressure (IOP) in glaucoma. This study aims to compare the efficacy and safety of trabeculectomy in Pakistani patients with MMC administration by sponges versus sub-tenon injection. Methods: A retrospective cohort study was conducted to analyze consecutive patients who underwent trabeculectomy with MMC at Aga Khan University Hospital, Karachi, Pakistan Complete success was defined as achieving an IOP of ≤ 15 mmHg at least one year one year post-surgery without additional anti-glaucoma medication. Qualified success was defined as IOP≤ 15 mmHg at least one year one year post-surgery with additional anti-glaucoma medications. Results: A total of 102 eyes from 67 patients were included in the study. Among the participants, 49%underwent trabeculectomy with MMC using the traditional sponges, while 51% underwent trabeculectomy with MMC via sub-tenon injection. At 12 months, the study revealed an overall success rate of 59% in the subtenon injection group versus 41% in the sponges group (p = 0.159) in controlling IOP. However, the sub-tenon injection group exhibited a trend towards lower IOP, achieving 100% complete surgical success versus 37% in the conventional sponges group along with displaying a lower frequency of post-operative complications (57% in the sponges-treated group vs 43% in the sub tenon injection group). Conclusion: Both MMC application techniques in trabeculectomy demonstrate similar efficacy and safety in Pakistani patients. The sub-tenon injection method emerges as a potentially safer alternative, offering benefits in lowering IOP and ensuring complete treatment success without the need for additional medications. Trabeculectomy Mitomycin C Sub-tenon injection Glaucoma Intraocular pressure Introduction Globally, glaucoma stands as the leading cause of permanent visual impairment, affecting approximately 7.7 million individuals worldwide [ 1 ]. A significant portion, nearly 60%, of those impacted by glaucoma hails from Asian countries [ 2 ]. In Pakistan alone, an estimated two million individuals grapple with this silent vision-threatening condition [ 3 ]. Elevated intraocular pressure (IOP) remains a well-established risk factor for the progression of glaucomatous optic neuropathy. Trabeculectomy persists as the surgery of choice for effective glaucoma control, particularly when conservative treatments like medications and laser therapies fall short of achieving the desired IOP reduction [ 4 , 5 ]. Despite its inherent limitations, trabeculectomy remains the gold standard of care [ 5 ]. Modifications such as the use of antimetabolites, adjustable sutures, and laser suture lysis have further refined the outcomes of the original Cairns (1968) trabeculectomy technique [ 6 ]. Nevertheless, the formation of surgical site scars remains a primary contributor to the challenges encountered in glaucoma surgeries [ 7 ]. In the 1980s, antifibrotics like mitomycin C (MMC) and 5-fluorouracil (5-FU) were introduced, significantly enhancing the success rate of filtration surgeries [ 8 , 9 ]. Derived from the fermented filtrate of Streptomyces caespitosus, MMC acts as an antiproliferative antibiotic agent, functioning as a DNA cross-linker to inhibit fibroblast proliferation and subsequent scar formation [ 10 ]. The conventional method of MMC application involves directly applying the medication via soaked sponges onto the sclera [ 5 ]. However, this approach has drawbacks, including increased surgical time and the potential for losing or retaining sponge fragments beneath the conjunctiva [ 11 ]. In contrast, a more recent MMC application technique, pioneered by Lee et al., entails injecting MMC into the Tenon's capsule before scleral flap dissection. This innovative approach holds promise in terms of surgical ease, safety, and outcomes [ 12 ]. A study by Guimarães et al. demonstrated that the sub-tenon injection method was as effective as the sponge method, with the added benefits of shorter surgery time and reduced complications associated with the sponge method [ 13 ]. Pakarvan et al. reported a success rate of 82.5% in reducing intraocular pressure (IOP), with the injection group displaying more favorable bleb characteristics and no significant difference in adverse effects [ 14 ]. Khouri et al. found that the MMC injection group exhibited lower postoperative IOP and comparable treatment success, defined as over a 30% IOP reduction without glaucoma medication [ 15 ]. These studies indicate that sub-tenon MMC injection is a viable, effective alternative to the conventional sponge method in trabeculectomy, offering similar safety and efficacy profiles. However, comprehensive comparative data in the Pakistani context are lacking. Our study aims to assess these methods in a Pakistani setting, focusing on success rates, outcomes, and complications, with success defined as maintaining an IOP ≤ 15 mmHg one-year post-surgery without additional anti-glaucoma medication. This comparison seeks to optimize surgical outcomes and enhance patient safety, contributing to the advancement of glaucoma treatment in Pakistan. Methodology This retrospective cohort study was conducted at the Department of Ophthalmology and Visual Sciences, Aga Khan University Hospital, Karachi, Pakistan. Medical records of 67 patients (102 eyes) who underwent trabeculectomy with intraoperative MMC for IOP control in primary open-angle glaucoma (POAG) between January 1, 2011, and December 31, 2021, were extracted. Patient records were identified using the hospital's information system and a surgery-specified code for trabeculectomy with MMC to minimize surgeon bias. All procedures were performed by a single surgeon (PSM). Patients with diagnoses other than POAG and those lost to follow-up within 6 months were excluded from the study. This study, conducted after obtaining Ethics Review Committee (ERC) approval, involved two groups: one group (n = 52) underwent trabeculectomy with MMC via subtenon injection, and the other had undergone (n = 50) trabeculectomy with MMC using traditional sponges. All surgeries involved a fornix-based trabeculectomy and were conducted under local anesthesia with a peribuar injection of 2% xylocaine, supplemented with topical proparacaine (Alcaine–Alcon, Belgium). A 6-O vicryl traction suture was inserted into the clear cornea superiorly. A small incision was made in the limbal conjunctiva at the 10 o'clock position, and the conjunctiva and tenon capsule were undermined. The MMC (Mitomycin-C, Kyowa – Japan) was injected using a blunt Rycroft cannula inserted at the limbus. The 0.1 ml of MMC was injected at 8 mm away from the limbus in the subtenon space A cotton tip applicator was used to prevent reflux of the drug. MMC was then distributed over the conjunctiva using a Weck-cell sponge. Peritomy was carried out from 11 o'clock to 1 o'clock with conjunctival undermining, followed by irrigation of the exposed scleral surface with 10 ml of Basic Salt Solution. After gentle cauterization, a partial-thickness scleral triangular flap measuring 4 x 4 mm was created. Before creating a 1 x 1 mm deeper corner sclerotomy with Kelly’s punch, the anterior chamber was filled and maintained with 1% sodium hyaluronate (Provisc – Alcon, Belgium). After surgical peripheral iridectomy, the scleral flap was closed with 10 − 0 nylon sutures. Postoperatively, care included Moxifloxacin 0.3% (Vigamox – Alcon, Pakistan) every hour for the first 24 hours, 2 hourly for 1 week, followed by 4 times a day for the next 4 weeks. Dexamethasone drops of 0.1% (Maxidex – Alcon, Pakistan) was started as one hourly for the first week, then tapered to two hourly for 4 weeks, subsequently reducing it to 4 times a day for another 4 weeks. In the conventional soaked sponges group, a standard fornix-based conjunctival incision was created. Three triangular cut cellulose sponges soaked with 0.02% MMC were placed subconjunctivally for 3 minutes; once sponges were removed, copious irrigation was performed in the area with a balanced salt solution. The rest of the surgical technique remained unchanged. Postoperative care followed the standard protocol. Data on patient demographics, comorbidities, pre-and post-operative corrected visual acuity (BCVA), pre-and post-operative intraocular pressure (IOP), central corneal thickness, pre-and post-operative anti-glaucoma medications, postoperative complications and interventions, and the need for further procedures were extracted. Follow-up occurred at 3, 6, and 12 months postoperatively. Postoperative complications included hypotony, leaking or over-filtrating bleb, hypotonic maculopathy, cystoid macular edema, hyphema, choroidal detachment, iris obstruction of the trabeculectomy ostium, blebitis, endophthalmitis, or cataract development. Success criteria included achieving an IOP of ≤ 15 mmHg one year after surgery without additional anti-glaucoma medication, with qualified success allowing for the use of additional antihypotensive agents. Data were analyzed using SPSS version 23. Qualitative variables were presented as frequencies and percentages, while quantitative variables were expressed as mean ± standard deviation (SD) or median (IQR, range). Chi-square/Fisher's exact test and independent t-test/Mann-Whitney U test were used to assess differences in qualitative and quantitative variables, respectively, between the two groups. Repeated measure ANOVA/Friedman test was applied to evaluate mean differences in IOP, visual acuity, and pachymetry values within and between groups for paired observations at 3, 6, and 12 months. Unadjusted and adjusted beta coefficients with 95% CI were obtained using multivariable linear regression (GEE) to assess the relationship between the technique type and other independent variables (complications, age, gender) with IOP. A p-value ≤ 0.05 was considered statistically significant. Results A total of 102 eyes from 67 patients were included in the study. The median age of participants was 54 years (Interquartile Range = 19), with 46 (69%) males and 21 (31%) females. All patients were of Pakistani origin with similar ethnic backgrounds. Out of 67 patients, 35 underwent bilateral surgeries. Among the 102 eyes, 50 (49%) underwent trabeculectomy with MMC using the traditional sponges method, while 52 (51%) underwent trabeculectomy with MMC via sub-tenon injection. Over the 12 months, both groups showed significant intragroup changes in IOP (p < 0.05), with significant intergroup differences observed only at the 12-month mark (p = 0.043). Baseline differences in best-corrected visual acuity (BCVA) were significant between groups (p = 0.006) but did not show significant intergroup differences at subsequent time points (Table 1 ). Table 1 Median IOP and BCVA at different time points in both groups. Time points Groups p-value Groups p-value IOP BCVA Sponges Injection Sponges Injection Pre-op 24 (22–43) 26 (22.25-32) 0.357 0.47 (0.09–1.09) 0.3 (0.09–0.47) 0.006* 3 months 14 (10–17) 11 (8–16) 0.314 0.3 (0.17-1) 0.3 (0.09–0.57) 0.553 6 months 13 (10-16.5) 12 (8–15) 0.348 0.17 (0.09–1.3) 0.3 (0.09–0.57) 0.942 12 months 14 (12.5–20.5) 12 (8–16) 0.043* 0.3 (0.17–1.65) 0.3 (0.09–0.87) 0.975 p-value 0.001* 0.001* 0.82 0.476 *Significant at a 5% level of significance To assess complete and qualified success, Fisher's exact test was used to analyze eyes achieving the desired IOP ≤ 15mmHg with and without additional anti-glaucoma drops. The qualified success rate did not significantly differ between the two MMC application techniques at 3, 6, and 12 months (p = 0.065, p = 0.076, and p = 0.159, respectively). Interestingly, though statistically non-significant, the sub-tenon MMC injection group achieved complete success without requiring anti-glaucoma drugs at all follow-ups (Table 2 ). Table 2 Patients with desired IOP ≤ 15mmHg achieved with (qualified success) or without (success) anti-glaucoma drugs. Time points Overall success Sponges Injection p-value Antiglaucoma drugs Antiglaucoma drugs Antiglaucoma drugs No Yes No Yes No Yes 3 months (n = 63) 60(95%) 03(5%) 23(36%) 03(5%) 37(59%) 0 0.065 6 months (n = 67) 64(95%) 03(5%) 26 (39%) 03(5%) 38 (56%) 0 0.076 12 months (n = 57) 55(96%) 02(4%) 21 (37%) 02(4%) 34 (59%) 0 0.159 A generalized estimated equation (GEE) with Bonferroni posthoc test was applied to test the difference in IOP control between the two techniques at pre-operatively and follow-ups at 3, 6, and 12 months. The injection-treated group exhibited lower IOP compared to the sponges-treated group, indicating a more effective treatment (p = 0.015). The sponges-treated group had an IOP of 4.28 higher than the injection-treated group. Pre-operative IOPs were significantly different between and within groups at all follow-ups (p = 0.005), while the differences among all follow-up IOPs were non-significant between and within groups (p > 0.05). Missing IOP data values were excluded from the analysis. Assessing the difference in BCVA between the two techniques pre-operatively and follow-ups at 3, 6, and 12 months, GEE with Bonferroni post hoc test revealed a non-significant difference in visual acuity between the sponges and injection groups at all-time points (p > 0.05). Missing data for BCVA results were excluded from the analysis. For patients with underlying comorbidities, the difference in IOP was assessed between procedures pre-operatively and follow-ups at 3, 6, and 12 months using GEE with Bonferroni post-hoc test. There was no significant difference in IOP between the injection and sponges-treated groups (p > 0.05). Pre-operative IOPs were significantly different between and within groups at all follow-ups (p = 0.005), while the differences among all follow-up IOPs were non-significant between and within groups (p > 0.05). Among the 102 eyes, 11 (11%) required additional surgery in the operating room. On the Chi-square test, there was no significant difference in re-operation rates between the sponges-treated group (n = 6) and the injection-treated group (n = 5) (p = 0.7). Additional minor procedures, including needling and/or suture lysis performed in the clinic, were also analyzed (Table 3 ). Table 3 In-patient re-operation or out-patient needling and/or suture lysis performed as per procedure (n = 101). Additional in-patient procedures (n = 11) Sponges Injection AGV with MMC 1 (9%) 0 Needling without MMC 0 2 (18%) Needling with MMC, and TSCPC 1 (9%) 0 Needling with MMC 1 (9%) 0 Needling + TSCPC 1 (9%) 0 Re-do Trabeculectomy 1 (9%) 0 Reformation of Bleb 1 (9%) 0 Removal of Corneal Suture 0 1 (9%) Suture-lysis 0 1 (9%) Total 6 (54%) 5 (36%) Additional out-patient procedures (n = 23) Sponges Injection Needling 5 (22%) 1 (4%) Needling with MMC 1 (4%) 4 (17%) Suture lysis 2 (9%) 9 (39%) Suture with needling 1 (4%) 0 Total 9 (39%) 14 (61%) n = Number of eyes Early and late postoperative complications within and after 3 months were evaluated, with three missing data values. Fisher's exact test showed no significant difference in complication rates between the two MMC application techniques both within and after 3 months of the procedure (p = 0.700) (Table 4 ). Table 4 Post-operative complications within and after 3 months of procedures. Within 3 Months Complications Sponges Injection Choroidal effusion 1 (11%) 0 Hypotony 2 (22%) 3 (33%) Over filtrating bleb 1 (11%) 0 Raised IOP 1 (11%) 0 Shallow AC 0 1 (11%) Total 5 (56%) 4 (44%) After 3 Months Complications Sponges Injection AC cells 1 (14%) 0 Blebitis + endophthalmitis- 0 1 (14%) Hypotony 0 1 (14%) Iris obstructing the ostium 0 1 (14%) Old choroidal effusion 1 (14%) 0 Raised IOP 1 (14%) 0 Right leaking bleb 1 (14%) 0 Total 4 (57%) 3 (43%) Discussion This study aimed to evaluate and compare the efficacy of two mitomycin C (MMC) application techniques (the conventional soaked-sponges method and the sub-tenon injection method) in trabeculectomy involving Pakistani patients. Results showed no significant difference in overall success rates, failure rates, intraocular pressure (IOP) control, and postoperative complications between the two methods at 6 and 12 months. This challenges the traditional preference for soaked sponges and suggests that the sub-tenon injection method is equally effective. This equivalence offers surgeons flexibility in choosing techniques based on patient-specific factors, surgical settings, and resource availability, with potential advantages for the sub-tenon injection method in settings prioritizing reduced surgical time and complexity. Our study aligns with Lee et al.'s initial findings [ 12 ], injecting the sub-tenon MMC with a 23 gauge needle and suggesting its effectiveness. However, their concentration of MMC varied between 0.2 to 0.5 mg/ml, and ours remained constant. Their study was based on a purely Caucasian population which is different from the Pakistani population in many ways. There were subtle differences in our techniques. Lee et al milked out the diluted MMC with the cannula and irrigated the injection site thrice. However, our study extends beyond by providing a more comprehensive and comparative analysis. In the broader context of glaucoma surgery, while trabeculectomy remains a mainstay, the approach to MMC application continues to evolve. MMC has consistently improved trabeculectomy success rates by reducing postoperative bleb scarring, a major cause of surgical failure. Our study contributes significant insights into the ongoing debate on the application method of MMC, particularly for Pakistani patients. We report similar success rates with both techniques, but the sub-tenon MMC injection group showed more favorable outcomes, aligning with findings by Quist et al. [ 16 ]. However, this contrasts with Lim et al. [ 17 ], indicating the need for further investigation. Notably, all successful cases in the sub-tenon MMC group did not require additional anti-glaucoma medication, indicating complete treatment success. This finding has implications for reducing reliance on anti-glaucoma medications and is similar to the studies by Shih et al. [ 18 ] and others. Our study reports an overall lower complication rate in the sub-tenon injection group, supporting the notion that it is a safer technique than the traditional method. This aligns with Pakravan et al.'s findings [ 6 ]. However, postoperative hypotony was more prevalent in the injection group, consistent with findings by Lim et al. and Quist et al. The intraocular toxicity of MMC may contribute to this hypotony, emphasizing the need for cautious application in eyes with thin sclera or conjunctiva. Strengths of our study include a robust sample size which increases the reliability and generalizability of the findings. All procedures were performed by a single surgeon, reducing potential variability in surgical technique and enhancing consistency in outcomes. The study provides insights that challenge traditional preferences in surgical techniques, suggesting equivalence between the sub-tenon injection method and the conventional soaked-sponges method in our population. This has practical implications for surgical decision-making and patient care. Overall, the study demonstrates methodological rigor, a comprehensive approach to data collection and analysis, and valuable insights into the efficacy and safety of different MMC application techniques in trabeculectomy. Limitations of our study include its retrospective nature, potential confounding variables, and the single-center design. Future research should focus on prospective, randomized trials, multi-center studies, and longer follow-up periods to validate these findings. Mechanistic differences between MMC application methods should be explored, and ongoing research is crucial as new technologies and approaches in glaucoma surgery emerge. Conclusion Our study compares the efficacy of different MMC application techniques in trabeculectomy performed on Pakistani patients. The equivalence in outcomes between conventional soaked sponges and the newer sub-tenon injection method suggests flexibility in surgical decision-making without compromising effectiveness. However, considering study limitations, further research is needed for a comprehensive understanding and optimization of glaucoma surgical outcomes. Declarations Conflict of interest None. Funding The authors declare that no funds, grants, or other support were received during the preparation of this manuscript. Author Contribution S.M. contributed to the study's conception and design and reviewed the manuscript.K.D. critically revised the manuscript for important intellectual content. H.Q. and R.A. collected the data for the studyZ.A. performed the data analysis. The first draft of the manuscript was written by H.Q. 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Effect of varying the mitomycin-C treatment area in glaucoma filtration surgery in the rabbit - PubMed (nih.gov) Onol M, Aktaş Z, Hasanreisoğlu B. Enhancement of the success rate in trabeculectomy: large-area mitomycin-C application. Clinical & experimental ophthalmology. 2008;36(4):316–22. DOI: 10.1111/j.1442-9071.2008.01736.x Mietz H, Diestelhorst M, Rump AF, Theisohn M, Klaus W, Krieglstein GK. Ocular concentrations of mitomycin C using different delivery devices. Ophthalmologica Journal international d'ophtalmologie International journal of ophthalmology Zeitschrift fur Augenheilkunde. 1998;212(1):37–42. DOI: 10.1159/000027257 Additional Declarations No competing interests reported. Supplementary Files Datasheetfortrabe.sav Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-4212897","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":287471125,"identity":"323f9ee7-e1fa-4f2c-8e64-955596d7f8c2","order_by":0,"name":"Hina Qazi","email":"","orcid":"","institution":"Aga Khan University Hospital","correspondingAuthor":false,"prefix":"","firstName":"Hina","middleName":"","lastName":"Qazi","suffix":""},{"id":287471126,"identity":"11679c16-593e-4fb2-be66-9824c8a2933e","order_by":1,"name":"Zehra Abdul","email":"","orcid":"","institution":"Aga Khan University Hospital","correspondingAuthor":false,"prefix":"","firstName":"Zehra","middleName":"","lastName":"Abdul","suffix":""},{"id":287471127,"identity":"72ec82a3-6aab-4803-8e94-a4c9315f76fc","order_by":2,"name":"Rida Ayub","email":"","orcid":"","institution":"Aga Khan University Hospital","correspondingAuthor":false,"prefix":"","firstName":"Rida","middleName":"","lastName":"Ayub","suffix":""},{"id":287471128,"identity":"87c316f5-0e87-4e2c-bce6-76cd907f9480","order_by":3,"name":"Karim Damji","email":"","orcid":"","institution":"Aga Khan University Hospital","correspondingAuthor":false,"prefix":"","firstName":"Karim","middleName":"","lastName":"Damji","suffix":""},{"id":287471129,"identity":"9b03ccd3-1b12-414c-a258-034c5b74e87a","order_by":4,"name":"Salim Mahar","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA1UlEQVRIiWNgGAWjYFAC5oYDIMqAgYHxAQOYmUBICyNcC7MB0VoYoFrYJIjSIt9+sPHQDYZt8ubsZ59V/DhzmIGfPccArxaDM4kNh3MYbhvu7Ek3u9lz4zCDZM8bAloYIFoYNxxIY7vB8+Ewg8ENArbI9z8Ea7HfcP4ZW+EfoBZ7QloYbkBsSdxwI42NmQfoMAMJQn65AbLF4HbyhhvPmKVlzqTzSJx5VkDAYcmHP+dU3LbdcD6N8eObY9Zy/O3JG/A7DGIXgslDhPJRMApGwSgYBYQAAM0qUPxfLq2RAAAAAElFTkSuQmCC","orcid":"","institution":"Aga Khan University Hospital","correspondingAuthor":true,"prefix":"","firstName":"Salim","middleName":"","lastName":"Mahar","suffix":""}],"badges":[],"createdAt":"2024-04-03 12:54:19","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-4212897/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-4212897/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":81357082,"identity":"ad181181-aa96-468d-83bf-31abae21ec75","added_by":"auto","created_at":"2025-04-25 07:47:08","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":804248,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-4212897/v1/c7816fa9-11fa-46b4-8699-a9bab07b9f62.pdf"},{"id":54452203,"identity":"909ca566-84d9-4655-9227-bcfd98189b2f","added_by":"auto","created_at":"2024-04-10 18:23:58","extension":"sav","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":43370,"visible":true,"origin":"","legend":"","description":"","filename":"Datasheetfortrabe.sav","url":"https://assets-eu.researchsquare.com/files/rs-4212897/v1/349a88a14d02bbc253d7c48c.sav"}],"financialInterests":"No competing interests reported.","formattedTitle":"Efficacy and Safety of Trabeculectomy in Pakistani Patients with Mitomycin C delivered via Sub Tenon Injection versus Conventional Soaked Sponges","fulltext":[{"header":"Introduction","content":"\u003cp\u003eGlobally, glaucoma stands as the leading cause of permanent visual impairment, affecting approximately 7.7\u0026nbsp;million individuals worldwide [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. A significant portion, nearly 60%, of those impacted by glaucoma hails from Asian countries [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e]. In Pakistan alone, an estimated two million individuals grapple with this silent vision-threatening condition [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e]. Elevated intraocular pressure (IOP) remains a well-established risk factor for the progression of glaucomatous optic neuropathy. Trabeculectomy persists as the surgery of choice for effective glaucoma control, particularly when conservative treatments like medications and laser therapies fall short of achieving the desired IOP reduction [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e, \u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]. Despite its inherent limitations, trabeculectomy remains the gold standard of care [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]. Modifications such as the use of antimetabolites, adjustable sutures, and laser suture lysis have further refined the outcomes of the original Cairns (1968) trabeculectomy technique [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]. Nevertheless, the formation of surgical site scars remains a primary contributor to the challenges encountered in glaucoma surgeries [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eIn the 1980s, antifibrotics like mitomycin C (MMC) and 5-fluorouracil (5-FU) were introduced, significantly enhancing the success rate of filtration surgeries [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e, \u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e]. Derived from the fermented filtrate of Streptomyces caespitosus, MMC acts as an antiproliferative antibiotic agent, functioning as a DNA cross-linker to inhibit fibroblast proliferation and subsequent scar formation [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e]. The conventional method of MMC application involves directly applying the medication via soaked sponges onto the sclera [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]. However, this approach has drawbacks, including increased surgical time and the potential for losing or retaining sponge fragments beneath the conjunctiva [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e]. In contrast, a more recent MMC application technique, pioneered by Lee et al., entails injecting MMC into the Tenon's capsule before scleral flap dissection. This innovative approach holds promise in terms of surgical ease, safety, and outcomes [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eA study by Guimar\u0026atilde;es et al. demonstrated that the sub-tenon injection method was as effective as the sponge method, with the added benefits of shorter surgery time and reduced complications associated with the sponge method [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e]. Pakarvan et al. reported a success rate of 82.5% in reducing intraocular pressure (IOP), with the injection group displaying more favorable bleb characteristics and no significant difference in adverse effects [\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e]. Khouri et al. found that the MMC injection group exhibited lower postoperative IOP and comparable treatment success, defined as over a 30% IOP reduction without glaucoma medication [\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e]. These studies indicate that sub-tenon MMC injection is a viable, effective alternative to the conventional sponge method in trabeculectomy, offering similar safety and efficacy profiles. However, comprehensive comparative data in the Pakistani context are lacking. Our study aims to assess these methods in a Pakistani setting, focusing on success rates, outcomes, and complications, with success defined as maintaining an IOP\u0026thinsp;\u0026le;\u0026thinsp;15 mmHg one-year post-surgery without additional anti-glaucoma medication. This comparison seeks to optimize surgical outcomes and enhance patient safety, contributing to the advancement of glaucoma treatment in Pakistan.\u003c/p\u003e"},{"header":"Methodology","content":"\u003cp\u003eThis retrospective cohort study was conducted at the Department of Ophthalmology and Visual Sciences, Aga Khan University Hospital, Karachi, Pakistan. Medical records of 67 patients (102 eyes) who underwent trabeculectomy with intraoperative MMC for IOP control in primary open-angle glaucoma (POAG) between January 1, 2011, and December 31, 2021, were extracted. Patient records were identified using the hospital's information system and a surgery-specified code for trabeculectomy with MMC to minimize surgeon bias. All procedures were performed by a single surgeon (PSM). Patients with diagnoses other than POAG and those lost to follow-up within 6 months were excluded from the study.\u003c/p\u003e \u003cp\u003eThis study, conducted after obtaining Ethics Review Committee (ERC) approval, involved two groups: one group (n\u0026thinsp;=\u0026thinsp;52) underwent trabeculectomy with MMC via subtenon injection, and the other had undergone (n\u0026thinsp;=\u0026thinsp;50) trabeculectomy with MMC using traditional sponges.\u003c/p\u003e \u003cp\u003eAll surgeries involved a fornix-based trabeculectomy and were conducted under local anesthesia with a peribuar injection of 2% xylocaine, supplemented with topical proparacaine (Alcaine\u0026ndash;Alcon, Belgium). A 6-O vicryl traction suture was inserted into the clear cornea superiorly. A small incision was made in the limbal conjunctiva at the 10 o'clock position, and the conjunctiva and tenon capsule were undermined. The MMC (Mitomycin-C, Kyowa \u0026ndash; Japan) was injected using a blunt Rycroft cannula inserted at the limbus. The 0.1 ml of MMC was injected at 8 mm away from the limbus in the subtenon space A cotton tip applicator was used to prevent reflux of the drug. MMC was then distributed over the conjunctiva using a Weck-cell sponge. Peritomy was carried out from 11 o'clock to 1 o'clock with conjunctival undermining, followed by irrigation of the exposed scleral surface with 10 ml of Basic Salt Solution.\u003c/p\u003e \u003cp\u003eAfter gentle cauterization, a partial-thickness scleral triangular flap measuring 4 x 4 mm was created. Before creating a 1 x 1 mm deeper corner sclerotomy with Kelly\u0026rsquo;s punch, the anterior chamber was filled and maintained with 1% sodium hyaluronate (Provisc \u0026ndash; Alcon, Belgium). After surgical peripheral iridectomy, the scleral flap was closed with 10\u0026thinsp;\u0026minus;\u0026thinsp;0 nylon sutures. Postoperatively, care included Moxifloxacin 0.3% (Vigamox \u0026ndash; Alcon, Pakistan) every hour for the first 24 hours, 2 hourly for 1 week, followed by 4 times a day for the next 4 weeks. Dexamethasone drops of 0.1% (Maxidex \u0026ndash; Alcon, Pakistan) was started as one hourly for the first week, then tapered to two hourly for 4 weeks, subsequently reducing it to 4 times a day for another 4 weeks.\u003c/p\u003e \u003cp\u003eIn the conventional soaked sponges group, a standard fornix-based conjunctival incision was created. Three triangular cut cellulose sponges soaked with 0.02% MMC were placed subconjunctivally for 3 minutes; once sponges were removed, copious irrigation was performed in the area with a balanced salt solution. The rest of the surgical technique remained unchanged. Postoperative care followed the standard protocol.\u003c/p\u003e \u003cp\u003eData on patient demographics, comorbidities, pre-and post-operative corrected visual acuity (BCVA), pre-and post-operative intraocular pressure (IOP), central corneal thickness, pre-and post-operative anti-glaucoma medications, postoperative complications and interventions, and the need for further procedures were extracted. Follow-up occurred at 3, 6, and 12 months postoperatively. Postoperative complications included hypotony, leaking or over-filtrating bleb, hypotonic maculopathy, cystoid macular edema, hyphema, choroidal detachment, iris obstruction of the trabeculectomy ostium, blebitis, endophthalmitis, or cataract development. Success criteria included achieving an IOP of \u0026le;\u0026thinsp;15 mmHg one year after surgery without additional anti-glaucoma medication, with qualified success allowing for the use of additional antihypotensive agents.\u003c/p\u003e \u003cp\u003eData were analyzed using SPSS version 23. Qualitative variables were presented as frequencies and percentages, while quantitative variables were expressed as mean\u0026thinsp;\u0026plusmn;\u0026thinsp;standard deviation (SD) or median (IQR, range). Chi-square/Fisher's exact test and independent t-test/Mann-Whitney U test were used to assess differences in qualitative and quantitative variables, respectively, between the two groups. Repeated measure ANOVA/Friedman test was applied to evaluate mean differences in IOP, visual acuity, and pachymetry values within and between groups for paired observations at 3, 6, and 12 months. Unadjusted and adjusted beta coefficients with 95% CI were obtained using multivariable linear regression (GEE) to assess the relationship between the technique type and other independent variables (complications, age, gender) with IOP. A p-value\u0026thinsp;\u0026le;\u0026thinsp;0.05 was considered statistically significant.\u003c/p\u003e"},{"header":"Results","content":"\u003cp\u003eA total of 102 eyes from 67 patients were included in the study. The median age of participants was 54 years (Interquartile Range\u0026thinsp;=\u0026thinsp;19), with 46 (69%) males and 21 (31%) females. All patients were of Pakistani origin with similar ethnic backgrounds. Out of 67 patients, 35 underwent bilateral surgeries. Among the 102 eyes, 50 (49%) underwent trabeculectomy with MMC using the traditional sponges method, while 52 (51%) underwent trabeculectomy with MMC via sub-tenon injection.\u003c/p\u003e \u003cp\u003eOver the 12 months, both groups showed significant intragroup changes in IOP (p\u0026thinsp;\u0026lt;\u0026thinsp;0.05), with significant intergroup differences observed only at the 12-month mark (p\u0026thinsp;=\u0026thinsp;0.043). Baseline differences in best-corrected visual acuity (BCVA) were significant between groups (p\u0026thinsp;=\u0026thinsp;0.006) but did not show significant intergroup differences at subsequent time points (Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003e\u003cb\u003eMedian IOP and BCVA at different time points in both groups.\u003c/b\u003e\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"7\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\" morerows=\"2\" rowspan=\"3\"\u003e \u003cp\u003eTime points\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e \u003cp\u003eGroups\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\" morerows=\"2\" rowspan=\"3\"\u003e \u003cp\u003ep-value\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"2\" nameend=\"c6\" namest=\"c5\"\u003e \u003cp\u003eGroups\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c7\" morerows=\"2\" rowspan=\"3\"\u003e \u003cp\u003ep-value\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e \u003cp\u003eIOP\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"2\" nameend=\"c6\" namest=\"c5\"\u003e \u003cp\u003eBCVA\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eSponges\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eInjection\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eSponges\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003eInjection\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003ePre-op\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e24 (22\u0026ndash;43)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e26 (22.25-32)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.357\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.47 (0.09\u0026ndash;1.09)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e0.3 (0.09\u0026ndash;0.47)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e0.006*\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003e3 months\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e14 (10\u0026ndash;17)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e11 (8\u0026ndash;16)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.314\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.3 (0.17-1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e0.3 (0.09\u0026ndash;0.57)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e0.553\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003e6 months\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e13 (10-16.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e12 (8\u0026ndash;15)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.348\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.17 (0.09\u0026ndash;1.3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e0.3 (0.09\u0026ndash;0.57)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e0.942\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003e12 months\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e14 (12.5\u0026ndash;20.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e12 (8\u0026ndash;16)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.043*\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.3 (0.17\u0026ndash;1.65)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e0.3 (0.09\u0026ndash;0.87)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e0.975\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003ep-value\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0.001*\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0.001*\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.82\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e0.476\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"7\"\u003e*Significant at a 5% level of significance\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eTo assess complete and qualified success, Fisher's exact test was used to analyze eyes achieving the desired IOP\u0026thinsp;\u0026le;\u0026thinsp;15mmHg with and without additional anti-glaucoma drops. The qualified success rate did not significantly differ between the two MMC application techniques at 3, 6, and 12 months (p\u0026thinsp;=\u0026thinsp;0.065, p\u0026thinsp;=\u0026thinsp;0.076, and p\u0026thinsp;=\u0026thinsp;0.159, respectively). Interestingly, though statistically non-significant, the sub-tenon MMC injection group achieved complete success without requiring anti-glaucoma drugs at all follow-ups (Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003e\u003cb\u003ePatients with desired IOP\u0026thinsp;\u0026le;\u0026thinsp;15mmHg achieved with (qualified success) or without (success) anti-glaucoma drugs.\u003c/b\u003e\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"8\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c8\" colnum=\"8\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\" morerows=\"2\" rowspan=\"3\"\u003e \u003cp\u003eTime points\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e \u003cp\u003eOverall success\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"2\" nameend=\"c5\" namest=\"c4\"\u003e \u003cp\u003eSponges\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"2\" nameend=\"c7\" namest=\"c6\"\u003e \u003cp\u003eInjection\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c8\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003ep-value\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e \u003cp\u003eAntiglaucoma drugs\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"2\" nameend=\"c5\" namest=\"c4\"\u003e \u003cp\u003eAntiglaucoma drugs\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"2\" nameend=\"c7\" namest=\"c6\"\u003e \u003cp\u003eAntiglaucoma drugs\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c7\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e3 months (n\u0026thinsp;=\u0026thinsp;63)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e60(95%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e03(5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e23(36%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e03(5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e37(59%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c8\"\u003e \u003cp\u003e0.065\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e6 months (n\u0026thinsp;=\u0026thinsp;67)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e64(95%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e03(5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e26 (39%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e03(5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e38 (56%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c8\"\u003e \u003cp\u003e0.076\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e12 months (n\u0026thinsp;=\u0026thinsp;57)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e55(96%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e02(4%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e21 (37%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e02(4%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e34 (59%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c8\"\u003e \u003cp\u003e0.159\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eA generalized estimated equation (GEE) with Bonferroni posthoc test was applied to test the difference in IOP control between the two techniques at pre-operatively and follow-ups at 3, 6, and 12 months. The injection-treated group exhibited lower IOP compared to the sponges-treated group, indicating a more effective treatment (p\u0026thinsp;=\u0026thinsp;0.015). The sponges-treated group had an IOP of 4.28 higher than the injection-treated group. Pre-operative IOPs were significantly different between and within groups at all follow-ups (p\u0026thinsp;=\u0026thinsp;0.005), while the differences among all follow-up IOPs were non-significant between and within groups (p\u0026thinsp;\u0026gt;\u0026thinsp;0.05). Missing IOP data values were excluded from the analysis.\u003c/p\u003e \u003cp\u003eAssessing the difference in BCVA between the two techniques pre-operatively and follow-ups at 3, 6, and 12 months, GEE with Bonferroni post hoc test revealed a non-significant difference in visual acuity between the sponges and injection groups at all-time points (p\u0026thinsp;\u0026gt;\u0026thinsp;0.05). Missing data for BCVA results were excluded from the analysis.\u003c/p\u003e \u003cp\u003eFor patients with underlying comorbidities, the difference in IOP was assessed between procedures pre-operatively and follow-ups at 3, 6, and 12 months using GEE with Bonferroni post-hoc test. There was no significant difference in IOP between the injection and sponges-treated groups (p\u0026thinsp;\u0026gt;\u0026thinsp;0.05). Pre-operative IOPs were significantly different between and within groups at all follow-ups (p\u0026thinsp;=\u0026thinsp;0.005), while the differences among all follow-up IOPs were non-significant between and within groups (p\u0026thinsp;\u0026gt;\u0026thinsp;0.05).\u003c/p\u003e \u003cp\u003eAmong the 102 eyes, 11 (11%) required additional surgery in the operating room. On the Chi-square test, there was no significant difference in re-operation rates between the sponges-treated group (n\u0026thinsp;=\u0026thinsp;6) and the injection-treated group (n\u0026thinsp;=\u0026thinsp;5) (p\u0026thinsp;=\u0026thinsp;0.7). Additional minor procedures, including needling and/or suture lysis performed in the clinic, were also analyzed (Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003e\u003cb\u003eIn-patient re-operation or out-patient needling and/or suture lysis performed as per procedure (n\u0026thinsp;=\u0026thinsp;101).\u003c/b\u003e\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"3\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAdditional in-patient procedures (n\u0026thinsp;=\u0026thinsp;11)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eSponges\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eInjection\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAGV with MMC\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1 (9%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNeedling without MMC\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2 (18%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNeedling with MMC, and TSCPC\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1 (9%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNeedling with MMC\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1 (9%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNeedling\u0026thinsp;+\u0026thinsp;TSCPC\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1 (9%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eRe-do Trabeculectomy\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1 (9%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eReformation of Bleb\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1 (9%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eRemoval of Corneal Suture\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1 (9%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSuture-lysis\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1 (9%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTotal\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e6 (54%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e5 (36%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eAdditional out-patient procedures (n\u0026thinsp;=\u0026thinsp;23)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003eSponges\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cb\u003eInjection\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNeedling\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e5 (22%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1 (4%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNeedling with MMC\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1 (4%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e4 (17%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSuture lysis\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2 (9%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e9 (39%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSuture with needling\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1 (4%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTotal\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e9 (39%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e14 (61%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"3\"\u003en\u0026thinsp;=\u0026thinsp;Number of eyes\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eEarly and late postoperative complications within and after 3 months were evaluated, with three missing data values. Fisher's exact test showed no significant difference in complication rates between the two MMC application techniques both within and after 3 months of the procedure (p\u0026thinsp;=\u0026thinsp;0.700) (Table\u0026nbsp;\u003cspan refid=\"Tab4\" class=\"InternalRef\"\u003e4\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab4\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 4\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003e\u003cb\u003ePost-operative complications within and after 3 months of procedures.\u003c/b\u003e\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"3\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eWithin 3 Months Complications\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eSponges\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eInjection\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eChoroidal effusion\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1 (11%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHypotony\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2 (22%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3 (33%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eOver filtrating bleb\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1 (11%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eRaised IOP\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1 (11%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eShallow AC\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1 (11%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTotal\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e5 (56%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e4 (44%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eAfter 3 Months Complications\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003eSponges\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cb\u003eInjection\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAC cells\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1 (14%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBlebitis\u0026thinsp;+\u0026thinsp;endophthalmitis-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1 (14%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHypotony\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1 (14%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eIris obstructing the ostium\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1 (14%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eOld choroidal effusion\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1 (14%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eRaised IOP\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1 (14%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eRight leaking bleb\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1 (14%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTotal\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e4 (57%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3 (43%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eThis study aimed to evaluate and compare the efficacy of two mitomycin C (MMC) application techniques (the conventional soaked-sponges method and the sub-tenon injection method) in trabeculectomy involving Pakistani patients. Results showed no significant difference in overall success rates, failure rates, intraocular pressure (IOP) control, and postoperative complications between the two methods at 6 and 12 months. This challenges the traditional preference for soaked sponges and suggests that the sub-tenon injection method is equally effective. This equivalence offers surgeons flexibility in choosing techniques based on patient-specific factors, surgical settings, and resource availability, with potential advantages for the sub-tenon injection method in settings prioritizing reduced surgical time and complexity.\u003c/p\u003e \u003cp\u003eOur study aligns with Lee et al.'s initial findings [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e], injecting the sub-tenon MMC with a 23 gauge needle and suggesting its effectiveness. However, their concentration of MMC varied between 0.2 to 0.5 mg/ml, and ours remained constant. Their study was based on a purely Caucasian population which is different from the Pakistani population in many ways. There were subtle differences in our techniques. Lee et al milked out the diluted MMC with the cannula and irrigated the injection site thrice. However, our study extends beyond by providing a more comprehensive and comparative analysis. In the broader context of glaucoma surgery, while trabeculectomy remains a mainstay, the approach to MMC application continues to evolve. MMC has consistently improved trabeculectomy success rates by reducing postoperative bleb scarring, a major cause of surgical failure. Our study contributes significant insights into the ongoing debate on the application method of MMC, particularly for Pakistani patients.\u003c/p\u003e \u003cp\u003eWe report similar success rates with both techniques, but the sub-tenon MMC injection group showed more favorable outcomes, aligning with findings by Quist et al. [\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e]. However, this contrasts with Lim et al. [\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e], indicating the need for further investigation. Notably, all successful cases in the sub-tenon MMC group did not require additional anti-glaucoma medication, indicating complete treatment success. This finding has implications for reducing reliance on anti-glaucoma medications and is similar to the studies by Shih et al. [\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e] and others.\u003c/p\u003e \u003cp\u003eOur study reports an overall lower complication rate in the sub-tenon injection group, supporting the notion that it is a safer technique than the traditional method. This aligns with Pakravan et al.'s findings [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]. However, postoperative hypotony was more prevalent in the injection group, consistent with findings by Lim et al. and Quist et al. The intraocular toxicity of MMC may contribute to this hypotony, emphasizing the need for cautious application in eyes with thin sclera or conjunctiva.\u003c/p\u003e \u003cp\u003eStrengths of our study include a robust sample size which increases the reliability and generalizability of the findings. All procedures were performed by a single surgeon, reducing potential variability in surgical technique and enhancing consistency in outcomes. The study provides insights that challenge traditional preferences in surgical techniques, suggesting equivalence between the sub-tenon injection method and the conventional soaked-sponges method in our population. This has practical implications for surgical decision-making and patient care. Overall, the study demonstrates methodological rigor, a comprehensive approach to data collection and analysis, and valuable insights into the efficacy and safety of different MMC application techniques in trabeculectomy.\u003c/p\u003e \u003cp\u003eLimitations of our study include its retrospective nature, potential confounding variables, and the single-center design. Future research should focus on prospective, randomized trials, multi-center studies, and longer follow-up periods to validate these findings. Mechanistic differences between MMC application methods should be explored, and ongoing research is crucial as new technologies and approaches in glaucoma surgery emerge.\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eOur study compares the efficacy of different MMC application techniques in trabeculectomy performed on Pakistani patients. The equivalence in outcomes between conventional soaked sponges and the newer sub-tenon injection method suggests flexibility in surgical decision-making without compromising effectiveness. However, considering study limitations, further research is needed for a comprehensive understanding and optimization of glaucoma surgical outcomes.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e \u003ch2\u003eConflict of interest\u003c/h2\u003e \u003cp\u003eNone.\u003c/p\u003e \u003ch2\u003eFunding\u003c/h2\u003e \u003cp\u003eThe authors declare that no funds, grants, or other support were received during the preparation of this manuscript.\u003c/p\u003e\u003ch2\u003eAuthor Contribution\u003c/h2\u003e\u003cp\u003eS.M. contributed to the study's conception and design and reviewed the manuscript.K.D. critically revised the manuscript for important intellectual content. H.Q. and R.A. collected the data for the studyZ.A. performed the data analysis. The first draft of the manuscript was written by H.Q. Z.A. and R.A.All authors reviewed and commented on previous versions of the manuscript.All authors read and approved the final manuscript.\u003c/p\u003e\u003ch2\u003eAcknowledgement\u003c/h2\u003e\u003cp\u003eWe would like to acknowledge Ms. Khadijah Abid for critically reviewing the manuscript.\u003c/p\u003e\u003ch2\u003eData Availability\u003c/h2\u003e\u003cp\u003eThe data of the manuscript is available as the supplementary file.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eWorld Health Organization. Blindness and vision impairment. World Health Organization; 2023. 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DOI: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.5005/jp-journals-10078-1254\u003c/span\u003e\u003cspan address=\"10.5005/jp-journals-10078-1254\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePakravan M, Esfandiari H, Yazdani S, Douzandeh A, Amouhashemi N, Yaseri M, Pakravan P. Mitomycin C-augmented trabeculectomy: sub tenon injection versus soaked sponges: a randomized clinical trial. British Journal of Ophthalmology. 2017;101(9):1275\u0026ndash;80 DOI: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1016/j.ogla.2018.06.003\u003c/span\u003e\u003cspan address=\"10.1016/j.ogla.2018.06.003\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eA SK, Huang G, L YH. Intraoperative Injection vs Sponge-applied Mitomycin C during Trabeculectomy: One-year Study. J Curr Glaucoma Pract. 2017;11(3):101\u0026ndash;6. DOI: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.5005/jp-journals-10028-1233\u003c/span\u003e\u003cspan address=\"10.5005/jp-journals-10028-1233\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eQuist MS, Brown N, Bicket AK, Herndon LW. The Short-term Effect of Subtenon Sponge Application Versus Subtenon Irrigation of Mitomycin-C on the Outcomes of Trabeculectomy With Ex-PRESS Glaucoma Filtration Device: A Randomized Trial. J Glaucoma. 2018;27(2):148\u0026ndash;56. DOI: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1097/IJG.0000000000000830\u003c/span\u003e\u003cspan address=\"10.1097/IJG.0000000000000830\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLim MC, Hom B, Watnik MR, Brandt JD, Altman AR, Paul T, Tong MG. A Comparison of Trabeculectomy Surgery Outcomes With Mitomycin-C Applied by Intra-Tenon Injection Versus Sponge. Am J Ophthalmol. 2020;216:243\u0026ndash;56. DOI:\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1016/j.ajo.2020.03.002\u003c/span\u003e\u003cspan address=\"10.1016/j.ajo.2020.03.002\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eShih EJ, Chen YY. Two-stage intra-tenon injection versus sponge-applied mitomycin C-augmented trabeculectomy: a one-year study. International ophthalmology. 2023;43(8):2593\u0026ndash;603. DOI: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1007/s10792-023-02658-6\u003c/span\u003e\u003cspan address=\"10.1007/s10792-023-02658-6\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eCordeiro MF, Constable PH, Alexander RA, Bhattacharya SS, Khaw PT. Effect of varying the mitomycin-C treatment area in glaucoma filtration surgery in the rabbit. Invest Ophthalmol Vis Sci. 1997;38(8):1639\u0026ndash;46. Effect of varying the mitomycin-C treatment area in glaucoma filtration surgery in the rabbit - PubMed (nih.gov)\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eOnol M, Aktaş Z, Hasanreisoğlu B. Enhancement of the success rate in trabeculectomy: large-area mitomycin-C application. Clinical \u0026amp; experimental ophthalmology. 2008;36(4):316\u0026ndash;22. DOI: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1111/j.1442-9071.2008.01736.x\u003c/span\u003e\u003cspan address=\"10.1111/j.1442-9071.2008.01736.x\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMietz H, Diestelhorst M, Rump AF, Theisohn M, Klaus W, Krieglstein GK. Ocular concentrations of mitomycin C using different delivery devices. Ophthalmologica Journal international d'ophtalmologie International journal of ophthalmology Zeitschrift fur Augenheilkunde. 1998;212(1):37\u0026ndash;42. DOI: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1159/000027257\u003c/span\u003e\u003cspan address=\"10.1159/000027257\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"
[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Trabeculectomy, Mitomycin C, Sub-tenon injection, Glaucoma, Intraocular pressure","lastPublishedDoi":"10.21203/rs.3.rs-4212897/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-4212897/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003ePurpose:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eTrabeculectomy with Mitomycin C (MMC) is a frequent choice for surgical intervention to effectively control intraocular pressure (IOP) in glaucoma. This study aims to compare the efficacy and safety of trabeculectomy in Pakistani patients with MMC administration by sponges versus sub-tenon injection.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eA retrospective cohort study was conducted to analyze consecutive patients who underwent trabeculectomy with MMC at Aga Khan University Hospital, Karachi, Pakistan\u003c/p\u003e\n\u003cp\u003eComplete success was defined as achieving an IOP of ≤ 15 mmHg at least one year one year post-surgery without additional anti-glaucoma medication. Qualified success was defined as IOP≤ 15 mmHg at least one year one year post-surgery with additional anti-glaucoma medications.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eA total of 102 eyes from 67 patients were included in the study. Among the participants, 49%underwent trabeculectomy with MMC using the traditional sponges, while 51% underwent trabeculectomy with MMC via sub-tenon injection. At 12 months, the study revealed an overall success rate of 59% in the subtenon injection group versus 41% in the sponges group (p = 0.159) in controlling IOP. \u0026nbsp;However, the sub-tenon injection group exhibited a trend towards lower IOP, achieving 100% complete surgical success versus 37% in the conventional sponges group along with displaying a lower frequency of post-operative complications (57% in the sponges-treated group vs 43% in the sub tenon injection group).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusion:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eBoth MMC application techniques in trabeculectomy demonstrate similar efficacy and safety in Pakistani patients. The sub-tenon injection method emerges as a potentially safer alternative, offering benefits in lowering IOP and ensuring complete treatment success without the need for additional medications.\u003c/p\u003e","manuscriptTitle":"Efficacy and Safety of Trabeculectomy in Pakistani Patients with Mitomycin C delivered via Sub Tenon Injection versus Conventional Soaked Sponges","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-04-10 18:23:53","doi":"10.21203/rs.3.rs-4212897/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"
[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"59459b08-3d49-4733-b6be-a4470291b95e","owner":[],"postedDate":"April 10th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2025-04-25T07:38:59+00:00","versionOfRecord":[],"versionCreatedAt":"2024-04-10 18:23:53","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-4212897","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-4212897","identity":"rs-4212897","version":["v1"]},"buildId":"qtupq5eGEP_6zYnWcrvyt","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}
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