Outcomes of Baerveldt Implantation for Pediatric Glaucoma Following Surgery: A Systematic Review and Meta-Analysis

Outcomes of Baerveldt Implantation for Pediatric Glaucoma Following Surgery: A Systematic Review and Meta-Analysis | 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 Outcomes of Baerveldt Implantation for Pediatric Glaucoma Following Surgery: A Systematic Review and Meta-Analysis Yousef Mesaed Al-Shammari^, Shaikhah Mesaed Al-Shammari^, Basel Bader, and 3 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-7821244/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 09 Dec, 2025 Read the published version in International Ophthalmology → Version 1 posted 11 You are reading this latest preprint version Abstract Background Pediatric glaucoma following surgery (GFS) remains a serious postoperative complication with potential for vision loss. Although glaucoma drainage devices are widely used in this setting, high-quality pooled evidence on the Baerveldt glaucoma implant (BGI) in children is limited. To systematically evaluate the efficacy and safety of BGI in pediatric patients with GFS. Methods Following PRISMA guidelines, five databases were searched up to August 2025. Eligible studies included pediatric cohorts (≤ 18 years) undergoing BGI after surgery, reporting intraocular pressure (IOP) outcomes or surgical success. Data were pooled using random-effects meta-analysis. Results Five studies (116 patients) met inclusion criteria. The mean age ranged from 3.0–7.8 years, with average follow-up of 31 months. The pooled success rate of IOP control was 84.5% (95% CI 0.75–0.91), with no evidence of heterogeneity. Hypotony occurred in 7.5%, choroidal effusion in 9%, and rare events included phthisis bulbi (2%), endophthalmitis (1.4%), and corneal decompensation (3.3%). Conclusion BGI provides effective and relatively safe IOP control after surgery, with complication rates comparable to or lower than alternative surgical options. However, evidence is constrained by limited sample size, retrospective design, and short- to mid-term follow-up. Long-term multicenter prospective trials are warranted. Baerveldt glaucoma review surgery Figures Figure 1 Figure 2 Figure 3 Figure 4 Figure 5 Figure 6 Figure 7 1.0 Introduction Pediatric glaucoma encompasses a spectrum of childhood-onset glaucomatous conditions characterized by elevated intraocular pressure, resulting in progressive optic nerve damage and potential irreversible blindness [ 1 ]. Clinically, it is divided into primary glaucomas, such as primary congenital glaucoma and juvenile open-angle glaucoma, and secondary glaucomas, which arise in association with other ocular or systemic disorders, most notably glaucoma following surgery [ 1 , 2 ]. Globally, PCG is rare but vision-threatening. Epidemiological data report incidence rates ranging from approximately 1 in 10,000 to 1 in 30,000 live births in Western countries, with significantly higher rates in populations with elevated consanguinity, up to 1 in 2,500 in parts of the Middle East or Slovakia [ 2 , 3 ] According to a population-based study in Minnesota, the overall incidence of childhood glaucoma was 2.29 per 100,000 residents under 20 years; secondary glaucoma had a notably higher incidence (0.45/100,000) compared to primary forms such as PCG (0.38/100,000) [ 4 ] GFCS, notably prevalent among secondary pediatric glaucomas, remains a serious postoperative complication. A large systematic review and meta-analysis published in 2024 found the pooled incidence of secondary glaucoma following congenital cataract surgery to be approximately 6.6%[ 5 ] Real-world cohort data reflect comparable frequencies: for instance, a study conducted in Sydney reported that 11.9% of eyes developed secondary glaucoma after pediatric surgery, often manifesting within 3 years postoperatively [ 6 ]In Sweden’s national pediatric registry, cumulative incidence of surgically managed glaucoma reached 23.7%, with most onset occurring within the first postoperative year [ 7 ] The Baerveldt implant is a non-valved, large-plate device engineered for sustained IOP control via capsule-mediated outflow once the tube is opened (typically after ligation) [ 8 ]. In adult randomized trials comparing Baerveldt with the Ahmed (valved, smaller plate), Baerveldt achieved lower IOP on fewer medications and lower reoperation rates, albeit with a higher risk of hypotony-related events, a trade-off relevant when extrapolating to children [ 9 ]. Pediatric comparative data, while more limited, show generally similar short- to mid-term success between Ahmed and Baerveldt over ~ 24 months [ 8 ]. Despite widespread clinical use, high-quality pooled evidence specific to BGI after surgery is limited. This systematic review and meta-analysis aimed to evaluate the efficacy and safety of Baerveldt glaucoma implantation in pediatric patients with glaucoma following surgery. 2.0 Methods This systematic review and meta-analysis adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines [ 10 ] and followed the methodological standards described in the Cochrane Handbook for Systematic Reviews of Interventions. Since the analysis was based exclusively on data from previously published studies, ethical approval was not required. The study protocol was prospectively registered with the PROSPERO database under the identifier (CRD420251146617). 2.1 Data Sources and Search Strategy A comprehensive systematic literature search was conducted on August 29, 2025, across five major electronic databases: PubMed, Scopus, Embase, the Cochrane Central Register of Controlled Trials (CENTRAL), and Web of Science (WOS). The search strategy combined terms related to the device, patient population, and clinical context. Specifically, keywords and synonyms included references to the Baerveldt implant and related glaucoma drainage devices. The full search strategy, including database-specific syntax and results, is presented in Table S1 . To enhance completeness, the reference lists of all eligible articles and relevant reviews were also manually screened to identify additional studies. 2.2 Eligibility criteria Studies were eligible for inclusion if they were randomized controlled trials, prospective cohort studies, or retrospective cohort studies involving pediatric patients aged 0–18 years at the time of glaucoma drainage device (GDD) implantation. Eligible interventions included the implantation of specified GDD models, Baerveldt implants (250, 350, 425). To be included, studies were required to report preoperative and postoperative intraocular pressure (IOP) and/or provide outcomes related to surgical success, with success defined according to clearly stated criteria. Exclusion criteria comprised studies in which GDD implantation was performed in combination with another intraocular surgery, those including eyes with a history of prior GDD implantation; and publications limited to case reports, conference abstracts, letters, review articles, or studies for which the full text was not available in English. 2.3 Study Selection Methods The process of study selection was carried out independently by two reviewers. Screening was performed in two stages: initially, titles and abstracts of all retrieved records were evaluated for relevance, followed by a detailed review of the full texts of potentially eligible studies. Disagreements at either stage were resolved through discussion until consensus was achieved. The same independent, duplicate assessment process was applied during the evaluation of risk of bias and statistical analyses to ensure methodological rigor and reliability of the findings. 2.4 Quality assessment The methodological quality and risk of bias of the included cohort studies were assessed using the National Institutes of Health (NIH) Quality Assessment Tool for Observational Cohort and Cross-Sectional Studies. This instrument evaluates 14 domains related to study design and conduct, including clarity of the research question, specification of the study population, participation rate, consistency in the selection of participants, justification of sample size, adequacy of exposure and outcome assessment, temporal relationship between exposure and outcome, adjustment for key confounders, and completeness of follow-up. Each item was rated as “yes,” “no,” “cannot determine,” “not applicable,” or “not reported.” Based on the overall appraisal of these criteria, studies were categorized as having good, fair, or poor quality, reflecting the likelihood of bias influencing the study findings. Two reviewers independently performed the quality assessments, and any disagreements were resolved through discussion until consensus was reached. 2.5 Meta-analysis Data from all eligible studies were extracted independently by two reviewers using a standardized data collection form. Extracted variables included study characteristics (author, year, country, design), patient demographics (age, sex, sample size), intervention details (type of glaucoma drainage device), and outcomes of interest (intraocular pressure [IOP], success rates, and postoperative complications). Any discrepancies in data extraction were resolved by discussion until consensus was reached. All statistical analyses were performed using OpenMeta Analyst software. Pooled proportions for each outcome were calculated with the Freeman–Tukey double arcsine transformation to stabilize variances. A random-effects model (DerSimonian–Laird method) was applied to account for potential between-study heterogeneity, and results were presented with corresponding 95% confidence intervals (CIs). Statistical heterogeneity was assessed using the I² statistic, with values of 25%, 50%, and 75% interpreted as low, moderate, and high heterogeneity, respectively. 3.0 Results 3.1 Search results A total of 358 records were initially identified through database searches: PubMed (n = 76), Cochrane Library (n = 3), Scopus (n = 124), Embase (n = 84), and Web of Science (n = 71). Following the removal of 186 duplicate entries, 172 unique records were retained for title and abstract screening. Of these, 166 were excluded based on the predefined eligibility criteria. The full texts of 6 reports were retrieved and assessed for eligibility, with one excluded due to reporting the wrong outcome. Ultimately, five studies satisfied the inclusion criteria and were incorporated into the review [ 9 , 11 – 14 ]. The entire search and selection process is presented in Fig. 1 . 3.2 Characteristics of the included studies A total of five studies encompassing 116 patients were included in the review [ 9 , 11 – 14 ]. The mean age of participants across studies ranged from 3.0 to 7.8 years. Regarding sex distribution, there were 66 males and 50 females. The duration of follow-up varied between 12 and 48 months, with an average follow-up across studies of approximately 31 months. Geographically, four studies were conducted in the United States, while one originated from Brazil. Table 1 Table 1 Characteristics of the included studies. Study Country Number of patients Mean age Sex (M, F) Follow up, months Conclusion Banitt et al., 2009 United States 30 6.9 14, 16 29.8 BGI surgery with pars plana tube insertion is a reasonable option for managing aphakic and pseudophakic children with uncontrolled glaucoma. Complications of BGI surgery related to anterior chamber tube placement, such as tube cornea touch, are minimized with this approach. The incidence of posterior segment complications, although possibly higher compared with limbal tube insertion, was not excessive. Budenz et al., 2000 United States 9 7.8 6, 3 35 Two-stage BGI surgery appears to be a safe and effective treatment for refractory glaucoma in children with SWS. Esfandiari et al., 2019 United States 28 4.2 16, 12 48 Glaucoma drainage device surgery results in good long-term outcomes in patients with GFCS. de-Moura et al., 2019 Brazil 13 3 9, 4 12 Both the tube and trabeculectomy groups presented similar intraocular pressure controls, but complete success was more frequent in the trabeculectomy group. Non-valved glaucoma drainage devices caused potentially blinding complications during tube opening. Tai et al., 2014 United States 36 4.3 21, 15 30 In this study cohort, BGI surgery effectively reduced IOP in pediatric patients with refractory glaucoma. 3.3 Quality assessment The risk of bias for the included cohort studies was evaluated using the NIH quality assessment tool. Based on the established criteria, all five studies were judged to demonstrate good methodological rigor, suggesting a low overall risk of bias. A detailed summary of the appraisal process, together with the ratings for each individual study, is provided in Table S2 . 3.4 Meta-analysis 3.4.1 Successful IOP control Four studies reported the outcome. The incidence of successful IOP control was significantly high (84.5%, 95%CI (0.75, 0.91), p < 0.001). The heterogeneity was zero (I 2 = 0%). Figure 2 3.4.2 Complications All included studies reported on hypotony, with a pooled incidence of 7.5% (95% CI: 0.01–0.16, p < 0.001). The level of heterogeneity was considered low (I² = 37%). Figure 3 Choroidal effusion was reported in four studies, showing a pooled incidence of 9% (95% CI: 0.02–0.18, p < 0.001), with no heterogeneity detected (I² = 0%). Figure 4 Three studies reported on phthisis bulbi (2%, 95% CI: 0.00–0.07, p = 0.01), endophthalmitis (1.4%, 95% CI: 0.00–0.06, p = 0.001), and corneal decompensation (3.3%, 95% CI: 0.00–0.10, p < 0.001). For all three outcomes, heterogeneity was absent (I² = 0%). Figures 5 – 7 4.0 Discussion This systematic review and meta-analysis provides a consolidated assessment of the outcomes of Baerveldt glaucoma implant (BGI) surgery in children with glaucoma following surgery. Across the five included studies, the pooled incidence of successful intraocular pressure (IOP) control was 84.5%, with no evidence of heterogeneity. This finding underscores the consistency and reliability of Baerveldt implantation in achieving stable IOP across different pediatric cohorts. The safety profile of the procedure was also favorable. Our pooled success rate for IOP control (84.5%) with low complication frequencies is broadly concordant with prior pediatric series of Baerveldt glaucoma implants (BGI). Large cohort analyses in children report high early success that diminishes with time, Jacobson et al. [ 15 ]observed ~ 84% success at 1 year falling to ~ 32% by 8 years, while van Overdam et al. [ 16 ]showed cumulative success of 94% at 12–24 months declining to 44% at 60 months. Given that follow-up in our included studies was 12–48 months, our estimates align with the time window when BGI success typically remains high. When contrasted with other drainage devices in pediatric glaucoma, short- to mid-term outcomes appear similar between Ahmed and Baerveldt implants. A recent pediatric meta-analysis found no difference in the proportion of success at 12 and 24 months between Ahmed and Baerveldt shunts, including in eyes with glaucoma following surgery, while both devices substantially reduced IOP for at least two years [ 17 ]. Pediatric Ahmed series likewise report moderate success, with device survival varying by etiology and a nontrivial risk of tube-related events. These data suggest that device choice in children may reasonably be individualized by anatomy, surgeon preference, and anticipated risk of hypotony [ 18 ]. Across the Ahmed–Baerveldt Comparison (ABC/AVB) trials [ 8 , 19 , 20 ], both devices lowered IOP and medications, but Baerveldt typically achieved lower IOP on fewer drops at the cost of a higher risk of hypotony-related or serious late complications; pooled 5-year analyses confirmed lower failure and reoperation rates for Baerveldt with an increased hypotony risk. Our pediatric meta-analysis found low pooled hypotony (7.5%), which may reflect routine tube ligation techniques in non-valved devices and careful patient selection in children, though direct pediatric RCTs are lacking. Comparisons with trabeculectomy further support the role of tubes in this setting. In glaucoma following pediatric surgery, trabeculectomy (even with mitomycin-C) has shown modest success and meaningful bleb-related risks. Mandal et al. reported only ~ 37% success at three years in GFCS, and classic pediatric series emphasize the long-term vulnerability to bleb infection [ 21 ]. Contemporary reviews of GFCS and pediatric GDDs accordingly position drainage devices as preferred options for refractory disease after angle-based procedures have failed or are unsuitable [ 22 – 24 ]. Our pooled low rates of endophthalmitis (1.4%) and corneal decompensation (3.3%) are consistent with this risk–benefit calculus, acknowledging differences in case mix and follow-up. Current consensus and clinical guidelines emphasize a staged, algorithm-based approach to pediatric glaucoma, guided by the Childhood Glaucoma Research Network (CGRN) classification framework. Initial surgical intervention typically involves angle surgery, such as goniotomy or trabeculotomy, especially in primary congenital glaucoma due to their high long-term success and preservation of conjunctiva for future surgeries [ 25 ] When these procedures fail or are not feasible, trabeculectomy with adjunctive mitomycin-C or glaucoma drainage device (GDD) implantation are recommended as second-line options, particularly in secondary glaucoma cases including glaucoma following surgery[ 26 ] GDDs are frequently preferred in refractory cases due to their ability to provide sustained IOP control and reduced reliance on blebs, which pose infection risks in children [ 25 ] Cyclodestructive procedures are reserved for advanced or inoperable cases due to their unpredictability and potential for vision loss [ 25 , 26 ] Current guidelines support a tiered surgical strategy that prioritizes angle procedures for primary forms and reserves GDDs for more complex or refractory pediatric glaucomas. Several limitations of this review should be acknowledged when interpreting the findings. First, the total sample size was relatively small, comprising only 116 patients across five studies. Such a limited cohort restricts the statistical power of the pooled analysis and may underestimate the true variability of outcomes. Second, most included studies were retrospective in design, which inherently introduces potential biases in patient selection, outcome reporting, and data completeness. Another notable limitation lies in the geographic distribution of the evidence, with four studies conducted in the United States and only one from Brazil. This limited diversity may affect the generalizability of the results to other healthcare settings with different surgical practices, patient demographics, or resource availability. Additionally, there was a lack of standardized definitions for certain outcomes, particularly regarding complications, which could contribute to variability in reporting. Finally, the duration of follow-up in the included studies ranged from 12 to 48 months, reflecting primarily short- to mid-term outcomes. As such, the long-term durability and safety of Baerveldt implantation in this pediatric population remain uncertain. To address these gaps, future investigations should prioritize multicenter, prospective, and ideally randomized studies that would provide more robust evidence and reduce inherent biases associated with retrospective designs. Comparative trials directly evaluating the Baerveldt implant against other glaucoma drainage devices, such as the Ahmed or Molteno implants, would be particularly valuable for guiding device selection in clinical practice. 5.0 Conclusion Baerveldt implantation demonstrates a high rate of intraocular pressure control with a low incidence of serious complications in pediatric glaucoma following surgery. Despite the encouraging outcomes, the current evidence is limited by small sample sizes, retrospective designs, and relatively short follow-up. Larger, multicenter prospective studies with long-term evaluation are essential to confirm durability, optimize patient selection, and guide evidence-based surgical decision-making in this challenging population. Declarations Funding Information: None. Data availability statement: The data generated in this study are available upon request from the corresponding author. Acknowledgements: None. 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1","display":"","copyAsset":false,"role":"figure","size":206938,"visible":true,"origin":"","legend":"\u003cp\u003eSee image above for figure legend\u0026nbsp;\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-7821244/v1/6e1284d5a87ea726d66d40c8.png"},{"id":94775555,"identity":"e831ed8b-89bc-480b-b9bd-2d8175731613","added_by":"auto","created_at":"2025-10-30 14:41:12","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":150907,"visible":true,"origin":"","legend":"\u003cp\u003eMeta-analysis of the successful IOP control.\u003c/p\u003e","description":"","filename":"2.png","url":"https://assets-eu.researchsquare.com/files/rs-7821244/v1/e29763cdd6b25c12c9cee803.png"},{"id":94825367,"identity":"abd8780b-65e9-4820-976c-a566e187ce36","added_by":"auto","created_at":"2025-10-31 06:50:09","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":159254,"visible":true,"origin":"","legend":"\u003cp\u003eMeta-analysis of hypotony.\u003c/p\u003e","description":"","filename":"3.png","url":"https://assets-eu.researchsquare.com/files/rs-7821244/v1/62d67e66de950f6b8ba8802d.png"},{"id":94824944,"identity":"ad1055c9-6923-498e-8718-ca631be68347","added_by":"auto","created_at":"2025-10-31 06:49:37","extension":"png","order_by":4,"title":"Figure 4","display":"","copyAsset":false,"role":"figure","size":151680,"visible":true,"origin":"","legend":"\u003cp\u003eMeta-analysis of choroidal effusion.\u003c/p\u003e","description":"","filename":"4.png","url":"https://assets-eu.researchsquare.com/files/rs-7821244/v1/737c012d1e3d38909cc2af2c.png"},{"id":94825212,"identity":"797e2a94-583c-4ccb-8d58-e13c28071194","added_by":"auto","created_at":"2025-10-31 06:49:58","extension":"png","order_by":5,"title":"Figure 5","display":"","copyAsset":false,"role":"figure","size":131820,"visible":true,"origin":"","legend":"\u003cp\u003eMeta-analysis of phthisis bulbi.\u003c/p\u003e","description":"","filename":"5.png","url":"https://assets-eu.researchsquare.com/files/rs-7821244/v1/a28dd669fd310b31518a42bf.png"},{"id":94825288,"identity":"29d7d150-5307-4e4b-b05d-5ece08ac55c9","added_by":"auto","created_at":"2025-10-31 06:50:05","extension":"png","order_by":6,"title":"Figure 6","display":"","copyAsset":false,"role":"figure","size":129116,"visible":true,"origin":"","legend":"\u003cp\u003eMeta-analysis of endophthalmitis.\u003c/p\u003e","description":"","filename":"6.png","url":"https://assets-eu.researchsquare.com/files/rs-7821244/v1/1f1ebe977f495ae96293a31f.png"},{"id":94825300,"identity":"62bfbd8f-e697-4d6a-a7f0-9002314982bb","added_by":"auto","created_at":"2025-10-31 06:50:05","extension":"png","order_by":7,"title":"Figure 7","display":"","copyAsset":false,"role":"figure","size":126459,"visible":true,"origin":"","legend":"\u003cp\u003eMeta-analysis of corneal decompensation.\u003c/p\u003e","description":"","filename":"7.png","url":"https://assets-eu.researchsquare.com/files/rs-7821244/v1/da261340055fc24fc9719549.png"},{"id":98243910,"identity":"0b95f84f-20bb-473d-8826-aeaae1085a99","added_by":"auto","created_at":"2025-12-15 16:11:14","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1489910,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-7821244/v1/3844c8da-73af-41f1-b978-f644380e6b41.pdf"},{"id":94775553,"identity":"1bcca8f5-9688-4d8e-8fcf-e0a0c388ab5e","added_by":"auto","created_at":"2025-10-30 14:41:12","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":19221,"visible":true,"origin":"","legend":"","description":"","filename":"Supplements.docx","url":"https://assets-eu.researchsquare.com/files/rs-7821244/v1/85e2433010b1060673727f7f.docx"}],"financialInterests":"No competing interests reported.","formattedTitle":"Outcomes of Baerveldt Implantation for Pediatric Glaucoma Following Surgery: A Systematic Review and Meta-Analysis","fulltext":[{"header":"1.0 Introduction","content":"\u003cp\u003ePediatric glaucoma encompasses a spectrum of childhood-onset glaucomatous conditions characterized by elevated intraocular pressure, resulting in progressive optic nerve damage and potential irreversible blindness [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. Clinically, it is divided into primary glaucomas, such as primary congenital glaucoma and juvenile open-angle glaucoma, and secondary glaucomas, which arise in association with other ocular or systemic disorders, most notably glaucoma following surgery [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e, \u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e]. Globally, PCG is rare but vision-threatening. Epidemiological data report incidence rates ranging from approximately 1 in 10,000 to 1 in 30,000 live births in Western countries, with significantly higher rates in populations with elevated consanguinity, up to 1 in 2,500 in parts of the Middle East or Slovakia [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e, \u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e] According to a population-based study in Minnesota, the overall incidence of childhood glaucoma was 2.29 per 100,000 residents under 20 years; secondary glaucoma had a notably higher incidence (0.45/100,000) compared to primary forms such as PCG (0.38/100,000) [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e]\u003c/p\u003e\u003cp\u003eGFCS, notably prevalent among secondary pediatric glaucomas, remains a serious postoperative complication. A large systematic review and meta-analysis published in 2024 found the pooled incidence of secondary glaucoma following congenital cataract surgery to be approximately 6.6%[\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e] Real-world cohort data reflect comparable frequencies: for instance, a study conducted in Sydney reported that 11.9% of eyes developed secondary glaucoma after pediatric surgery, often manifesting within 3 years postoperatively [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]In Sweden\u0026rsquo;s national pediatric registry, cumulative incidence of surgically managed glaucoma reached 23.7%, with most onset occurring within the first postoperative year [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e]\u003c/p\u003e\u003cp\u003eThe Baerveldt implant is a non-valved, large-plate device engineered for sustained IOP control via capsule-mediated outflow once the tube is opened (typically after ligation) [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e]. In adult randomized trials comparing Baerveldt with the Ahmed (valved, smaller plate), Baerveldt achieved lower IOP on fewer medications and lower reoperation rates, albeit with a higher risk of hypotony-related events, a trade-off relevant when extrapolating to children [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e]. Pediatric comparative data, while more limited, show generally similar short- to mid-term success between Ahmed and Baerveldt over ~\u0026thinsp;24 months [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eDespite widespread clinical use, high-quality pooled evidence specific to BGI after surgery is limited. This systematic review and meta-analysis aimed to evaluate the efficacy and safety of Baerveldt glaucoma implantation in pediatric patients with glaucoma following surgery.\u003c/p\u003e"},{"header":"2.0 Methods","content":"\u003cp\u003eThis systematic review and meta-analysis adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e] and followed the methodological standards described in the Cochrane Handbook for Systematic Reviews of Interventions. Since the analysis was based exclusively on data from previously published studies, ethical approval was not required. The study protocol was prospectively registered with the PROSPERO database under the identifier (CRD420251146617).\u003c/p\u003e\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e\u003ch2\u003e2.1 Data Sources and Search Strategy\u003c/h2\u003e\u003cp\u003eA comprehensive systematic literature search was conducted on August 29, 2025, across five major electronic databases: PubMed, Scopus, Embase, the Cochrane Central Register of Controlled Trials (CENTRAL), and Web of Science (WOS). The search strategy combined terms related to the device, patient population, and clinical context. Specifically, keywords and synonyms included references to the Baerveldt implant and related glaucoma drainage devices. The full search strategy, including database-specific syntax and results, is presented in \u003cb\u003eTable \u003cspan refid=\"MOESM1\" class=\"InternalRef\"\u003eS1\u003c/span\u003e\u003c/b\u003e. To enhance completeness, the reference lists of all eligible articles and relevant reviews were also manually screened to identify additional studies.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec4\" class=\"Section2\"\u003e\u003ch2\u003e2.2 Eligibility criteria\u003c/h2\u003e\u003cp\u003eStudies were eligible for inclusion if they were randomized controlled trials, prospective cohort studies, or retrospective cohort studies involving pediatric patients aged 0\u0026ndash;18 years at the time of glaucoma drainage device (GDD) implantation. Eligible interventions included the implantation of specified GDD models, Baerveldt implants (250, 350, 425). To be included, studies were required to report preoperative and postoperative intraocular pressure (IOP) and/or provide outcomes related to surgical success, with success defined according to clearly stated criteria. Exclusion criteria comprised studies in which GDD implantation was performed in combination with another intraocular surgery, those including eyes with a history of prior GDD implantation; and publications limited to case reports, conference abstracts, letters, review articles, or studies for which the full text was not available in English.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec5\" class=\"Section2\"\u003e\u003ch2\u003e2.3 Study Selection Methods\u003c/h2\u003e\u003cp\u003eThe process of study selection was carried out independently by two reviewers. Screening was performed in two stages: initially, titles and abstracts of all retrieved records were evaluated for relevance, followed by a detailed review of the full texts of potentially eligible studies. Disagreements at either stage were resolved through discussion until consensus was achieved. The same independent, duplicate assessment process was applied during the evaluation of risk of bias and statistical analyses to ensure methodological rigor and reliability of the findings.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec6\" class=\"Section2\"\u003e\u003ch2\u003e2.4 Quality assessment\u003c/h2\u003e\u003cp\u003eThe methodological quality and risk of bias of the included cohort studies were assessed using the National Institutes of Health (NIH) Quality Assessment Tool for Observational Cohort and Cross-Sectional Studies. This instrument evaluates 14 domains related to study design and conduct, including clarity of the research question, specification of the study population, participation rate, consistency in the selection of participants, justification of sample size, adequacy of exposure and outcome assessment, temporal relationship between exposure and outcome, adjustment for key confounders, and completeness of follow-up. Each item was rated as \u0026ldquo;yes,\u0026rdquo; \u0026ldquo;no,\u0026rdquo; \u0026ldquo;cannot determine,\u0026rdquo; \u0026ldquo;not applicable,\u0026rdquo; or \u0026ldquo;not reported.\u0026rdquo; Based on the overall appraisal of these criteria, studies were categorized as having good, fair, or poor quality, reflecting the likelihood of bias influencing the study findings. Two reviewers independently performed the quality assessments, and any disagreements were resolved through discussion until consensus was reached.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec7\" class=\"Section2\"\u003e\u003ch2\u003e2.5 Meta-analysis\u003c/h2\u003e\u003cp\u003eData from all eligible studies were extracted independently by two reviewers using a standardized data collection form. Extracted variables included study characteristics (author, year, country, design), patient demographics (age, sex, sample size), intervention details (type of glaucoma drainage device), and outcomes of interest (intraocular pressure [IOP], success rates, and postoperative complications). Any discrepancies in data extraction were resolved by discussion until consensus was reached. All statistical analyses were performed using OpenMeta Analyst software. Pooled proportions for each outcome were calculated with the Freeman\u0026ndash;Tukey double arcsine transformation to stabilize variances. A random-effects model (DerSimonian\u0026ndash;Laird method) was applied to account for potential between-study heterogeneity, and results were presented with corresponding 95% confidence intervals (CIs). Statistical heterogeneity was assessed using the I\u0026sup2; statistic, with values of 25%, 50%, and 75% interpreted as low, moderate, and high heterogeneity, respectively.\u003c/p\u003e\u003c/div\u003e"},{"header":"3.0 Results","content":"\u003cdiv id=\"Sec9\" class=\"Section2\"\u003e\u003ch2\u003e3.1 Search results\u003c/h2\u003e\u003cp\u003eA total of 358 records were initially identified through database searches: PubMed (n\u0026thinsp;=\u0026thinsp;76), Cochrane Library (n\u0026thinsp;=\u0026thinsp;3), Scopus (n\u0026thinsp;=\u0026thinsp;124), Embase (n\u0026thinsp;=\u0026thinsp;84), and Web of Science (n\u0026thinsp;=\u0026thinsp;71). Following the removal of 186 duplicate entries, 172 unique records were retained for title and abstract screening. Of these, 166 were excluded based on the predefined eligibility criteria. The full texts of 6 reports were retrieved and assessed for eligibility, with one excluded due to reporting the wrong outcome. Ultimately, five studies satisfied the inclusion criteria and were incorporated into the review [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e, \u003cspan additionalcitationids=\"CR12 CR13\" citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e]. The entire search and selection process is presented in Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e.\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec10\" class=\"Section2\"\u003e\u003ch2\u003e3.2 Characteristics of the included studies\u003c/h2\u003e\u003cp\u003eA total of five studies encompassing 116 patients were included in the review [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e, \u003cspan additionalcitationids=\"CR12 CR13\" citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e]. The mean age of participants across studies ranged from 3.0 to 7.8 years. Regarding sex distribution, there were 66 males and 50 females. The duration of follow-up varied between 12 and 48 months, with an average follow-up across studies of approximately 31 months. Geographically, four studies were conducted in the United States, while one originated from Brazil. 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\u003eCharacteristics of the included studies.\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=\"char\" char=\".\" 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=\"left\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003eStudy\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eCountry\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eNumber of patients\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u003cp\u003eMean age\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c5\"\u003e\u003cp\u003eSex (M, F)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c6\"\u003e\u003cp\u003eFollow up, months\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c7\"\u003e\u003cp\u003eConclusion\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eBanitt et al., 2009\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eUnited States\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e30\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e6.9\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e14, 16\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e29.8\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003eBGI surgery with pars plana tube insertion is a reasonable option for managing aphakic and pseudophakic children with uncontrolled glaucoma. Complications of BGI surgery related to anterior chamber tube placement, such as tube cornea touch, are minimized with this approach. The incidence of posterior segment complications, although possibly higher compared with limbal tube insertion, was not excessive.\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eBudenz et al., 2000\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eUnited States\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e9\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e7.8\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e6, 3\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e35\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003eTwo-stage BGI surgery appears to be a safe and effective treatment for refractory glaucoma in children with SWS.\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eEsfandiari et al., 2019\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eUnited States\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e28\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e4.2\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e16, 12\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e48\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003eGlaucoma drainage device surgery results in good\u003c/p\u003e\u003cp\u003e long-term outcomes in patients with GFCS.\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003ede-Moura et al., 2019\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eBrazil\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e13\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e3\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e9, 4\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e12\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003eBoth the tube and trabeculectomy groups presented similar intraocular pressure controls, but complete success was more frequent in the trabeculectomy group. Non-valved glaucoma drainage devices caused potentially blinding complications during tube opening.\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eTai et al., 2014\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eUnited States\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e36\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e4.3\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e21, 15\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e30\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003eIn this study cohort, BGI surgery effectively reduced IOP in pediatric patients with refractory glaucoma.\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec11\" class=\"Section2\"\u003e\u003ch2\u003e3.3 Quality assessment\u003c/h2\u003e\u003cp\u003eThe risk of bias for the included cohort studies was evaluated using the NIH quality assessment tool. Based on the established criteria, all five studies were judged to demonstrate good methodological rigor, suggesting a low overall risk of bias. A detailed summary of the appraisal process, together with the ratings for each individual study, is provided in \u003cb\u003eTable S2\u003c/b\u003e.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec12\" class=\"Section2\"\u003e\u003ch2\u003e3.4 Meta-analysis\u003c/h2\u003e\u003cdiv id=\"Sec13\" class=\"Section3\"\u003e\u003ch2\u003e3.4.1 Successful IOP control\u003c/h2\u003e\u003cp\u003eFour studies reported the outcome. The incidence of successful IOP control was significantly high (84.5%, 95%CI (0.75, 0.91), p\u0026thinsp;\u0026lt;\u0026thinsp;0.001). The heterogeneity was zero (I\u003csup\u003e2\u003c/sup\u003e\u0026thinsp;=\u0026thinsp;0%). Figure\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec14\" class=\"Section3\"\u003e\u003ch2\u003e3.4.2 Complications\u003c/h2\u003e\u003cp\u003eAll included studies reported on hypotony, with a pooled incidence of 7.5% (95% CI: 0.01\u0026ndash;0.16, p\u0026thinsp;\u0026lt;\u0026thinsp;0.001). The level of heterogeneity was considered low (I\u0026sup2; = 37%). Figure\u0026nbsp;\u003cspan refid=\"Fig3\" class=\"InternalRef\"\u003e3\u003c/span\u003e\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003cp\u003eChoroidal effusion was reported in four studies, showing a pooled incidence of 9% (95% CI: 0.02\u0026ndash;0.18, p\u0026thinsp;\u0026lt;\u0026thinsp;0.001), with no heterogeneity detected (I\u0026sup2; = 0%). Figure\u0026nbsp;\u003cspan refid=\"Fig4\" class=\"InternalRef\"\u003e4\u003c/span\u003e\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003cp\u003eThree studies reported on phthisis bulbi (2%, 95% CI: 0.00\u0026ndash;0.07, p\u0026thinsp;=\u0026thinsp;0.01), endophthalmitis (1.4%, 95% CI: 0.00\u0026ndash;0.06, p\u0026thinsp;=\u0026thinsp;0.001), and corneal decompensation (3.3%, 95% CI: 0.00\u0026ndash;0.10, p\u0026thinsp;\u0026lt;\u0026thinsp;0.001). For all three outcomes, heterogeneity was absent (I\u0026sup2; = 0%). Figures\u0026nbsp;\u003cspan refid=\"Fig5\" class=\"InternalRef\"\u003e5\u003c/span\u003e\u0026ndash;\u003cspan refid=\"Fig7\" class=\"InternalRef\"\u003e7\u003c/span\u003e\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e"},{"header":"4.0 Discussion","content":"\u003cp\u003e This systematic review and meta-analysis provides a consolidated assessment of the outcomes of Baerveldt glaucoma implant (BGI) surgery in children with glaucoma following surgery. Across the five included studies, the pooled incidence of successful intraocular pressure (IOP) control was 84.5%, with no evidence of heterogeneity. This finding underscores the consistency and reliability of Baerveldt implantation in achieving stable IOP across different pediatric cohorts. The safety profile of the procedure was also favorable.\u003c/p\u003e\u003cp\u003eOur pooled success rate for IOP control (84.5%) with low complication frequencies is broadly concordant with prior pediatric series of Baerveldt glaucoma implants (BGI). Large cohort analyses in children report high early success that diminishes with time, Jacobson et al. [\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e]observed\u0026thinsp;~\u0026thinsp;84% success at 1 year falling to ~\u0026thinsp;32% by 8 years, while van Overdam et al. [\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e]showed cumulative success of 94% at 12\u0026ndash;24 months declining to 44% at 60 months. Given that follow-up in our included studies was 12\u0026ndash;48 months, our estimates align with the time window when BGI success typically remains high. When contrasted with other drainage devices in pediatric glaucoma, short- to mid-term outcomes appear similar between Ahmed and Baerveldt implants. A recent pediatric meta-analysis found no difference in the proportion of success at 12 and 24 months between Ahmed and Baerveldt shunts, including in eyes with glaucoma following surgery, while both devices substantially reduced IOP for at least two years [\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e]. Pediatric Ahmed series likewise report moderate success, with device survival varying by etiology and a nontrivial risk of tube-related events. These data suggest that device choice in children may reasonably be individualized by anatomy, surgeon preference, and anticipated risk of hypotony [\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eAcross the Ahmed\u0026ndash;Baerveldt Comparison (ABC/AVB) trials [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e, \u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e, \u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e], both devices lowered IOP and medications, but Baerveldt typically achieved lower IOP on fewer drops at the cost of a higher risk of hypotony-related or serious late complications; pooled 5-year analyses confirmed lower failure and reoperation rates for Baerveldt with an increased hypotony risk. Our pediatric meta-analysis found low pooled hypotony (7.5%), which may reflect routine tube ligation techniques in non-valved devices and careful patient selection in children, though direct pediatric RCTs are lacking.\u003c/p\u003e\u003cp\u003eComparisons with trabeculectomy further support the role of tubes in this setting. In glaucoma following pediatric surgery, trabeculectomy (even with mitomycin-C) has shown modest success and meaningful bleb-related risks. Mandal et al. reported only\u0026thinsp;~\u0026thinsp;37% success at three years in GFCS, and classic pediatric series emphasize the long-term vulnerability to bleb infection [\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e]. Contemporary reviews of GFCS and pediatric GDDs accordingly position drainage devices as preferred options for refractory disease after angle-based procedures have failed or are unsuitable [\u003cspan additionalcitationids=\"CR23\" citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e]. Our pooled low rates of endophthalmitis (1.4%) and corneal decompensation (3.3%) are consistent with this risk\u0026ndash;benefit calculus, acknowledging differences in case mix and follow-up.\u003c/p\u003e\u003cp\u003e Current consensus and clinical guidelines emphasize a staged, algorithm-based approach to pediatric glaucoma, guided by the Childhood Glaucoma Research Network (CGRN) classification framework. Initial surgical intervention typically involves angle surgery, such as goniotomy or trabeculotomy, especially in primary congenital glaucoma due to their high long-term success and preservation of conjunctiva for future surgeries [\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e] When these procedures fail or are not feasible, trabeculectomy with adjunctive mitomycin-C or glaucoma drainage device (GDD) implantation are recommended as second-line options, particularly in secondary glaucoma cases including glaucoma following surgery[\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e] GDDs are frequently preferred in refractory cases due to their ability to provide sustained IOP control and reduced reliance on blebs, which pose infection risks in children [\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e] Cyclodestructive procedures are reserved for advanced or inoperable cases due to their unpredictability and potential for vision loss [\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e, \u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e] Current guidelines support a tiered surgical strategy that prioritizes angle procedures for primary forms and reserves GDDs for more complex or refractory pediatric glaucomas.\u003c/p\u003e\u003cp\u003eSeveral limitations of this review should be acknowledged when interpreting the findings. First, the total sample size was relatively small, comprising only 116 patients across five studies. Such a limited cohort restricts the statistical power of the pooled analysis and may underestimate the true variability of outcomes. Second, most included studies were retrospective in design, which inherently introduces potential biases in patient selection, outcome reporting, and data completeness. Another notable limitation lies in the geographic distribution of the evidence, with four studies conducted in the United States and only one from Brazil. This limited diversity may affect the generalizability of the results to other healthcare settings with different surgical practices, patient demographics, or resource availability. Additionally, there was a lack of standardized definitions for certain outcomes, particularly regarding complications, which could contribute to variability in reporting. Finally, the duration of follow-up in the included studies ranged from 12 to 48 months, reflecting primarily short- to mid-term outcomes. As such, the long-term durability and safety of Baerveldt implantation in this pediatric population remain uncertain. To address these gaps, future investigations should prioritize multicenter, prospective, and ideally randomized studies that would provide more robust evidence and reduce inherent biases associated with retrospective designs. Comparative trials directly evaluating the Baerveldt implant against other glaucoma drainage devices, such as the Ahmed or Molteno implants, would be particularly valuable for guiding device selection in clinical practice.\u003c/p\u003e"},{"header":"5.0 Conclusion","content":"\u003cp\u003eBaerveldt implantation demonstrates a high rate of intraocular pressure control with a low incidence of serious complications in pediatric glaucoma following surgery. Despite the encouraging outcomes, the current evidence is limited by small sample sizes, retrospective designs, and relatively short follow-up. Larger, multicenter prospective studies with long-term evaluation are essential to confirm durability, optimize patient selection, and guide evidence-based surgical decision-making in this challenging population.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003eFunding Information: None.\u003c/p\u003e\n\u003cp\u003eData availability statement:\u003c/p\u003e\n\u003cp\u003eThe data generated in this study are available upon request from the corresponding author.\u003c/p\u003e\n\u003cp\u003eAcknowledgements: None.\u003c/p\u003e\n\u003cp\u003eConflict of Interest Statement: The authors declare no competing financial\u0026nbsp;interests.\u003c/p\u003e\n"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eKnight LSW, Ruddle JB, Taranath DA, et al.: Childhood and Early Onset Glaucoma Classification and Genetic Profile in a Large Australasian Disease Registry. Ophthalmology. 2021, 128:1549\u0026ndash;60. 10.1016/j.ophtha.2021.04.016\u003c/li\u003e\n\u003cli\u003eAbdolrahimzadeh S, Fameli V, Mollo R, Contestabile MT, Perdicchi A, Recupero SM: Rare Diseases Leading to Childhood Glaucoma: Epidemiology, Pathophysiogenesis, and Management. Biomed Res Int. 2015, 2015:1\u0026ndash;11. 10.1155/2015/781294\u003c/li\u003e\n\u003cli\u003eJemmeih S, Malik S, Okashah S, Zayed H: Genetic Epidemiology of Primary Congenital Glaucoma in the 22 Arab Countries: A Systematic Review. Ophthalmic Epidemiol. 2022, 29:1\u0026ndash;12. 10.1080/09286586.2021.1883676\u003c/li\u003e\n\u003cli\u003eAponte EP: Incidence and Clinical Characteristics of Childhood Glaucoma. Archives of Ophthalmology. 2010, 128:478. 10.1001/archophthalmol.2010.41\u003c/li\u003e\n\u003cli\u003eLi L, Wang X, Liu C, Wang S, Wang X: Incidence Rate of Secondary Glaucoma Following Congenital Cataract Surgery: An In-Depth Systematic Review and Meta-Analysis. Am J Ophthalmol. 2024, 265:176\u0026ndash;88. 10.1016/j.ajo.2024.04.021\u003c/li\u003e\n\u003cli\u003eWood A, Lim B, Matthews J, et al.: Prevalence of Glaucoma Following Paediatric Cataract Surgery in an Australian Tertiary Referral Centre. Clinical Ophthalmology. 2023, Volume 17:2171\u0026ndash;9. 10.2147/OPTH.S400512\u003c/li\u003e\n\u003cli\u003eNystr\u0026ouml;m A, Haargaard B, Rosensv\u0026auml;rd A, Tornqvist K, Magnusson G: The Swedish National Pediatric Cataract Register (PECARE): incidence and onset of postoperative glaucoma. Acta Ophthalmol. 2020, 98:654\u0026ndash;61. 10.1111/aos.14414\u003c/li\u003e\n\u003cli\u003eBudenz DL, Feuer WJ, Barton K, et al.: Postoperative Complications in the Ahmed Baerveldt Comparison Study During Five Years of Follow-up. Am J Ophthalmol. 2016, 163:75-82.e3. 10.1016/j.ajo.2015.11.023\u003c/li\u003e\n\u003cli\u003eRolim-de-Moura C, Esporcatte BLB, Netto CF, Paranhos A: Baerveldt implant versus trabeculectomy as the first filtering surgery for uncontrolled primary congenital glaucoma: A randomized clinical trial. Arq Bras Oftalmol. 2020, 83:215\u0026ndash;24. 10.5935/0004-2749.20200060\u003c/li\u003e\n\u003cli\u003ePage MJ, McKenzie JE, Bossuyt PM, et al.: The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ. 2021, n71. 10.1136/bmj.n71\u003c/li\u003e\n\u003cli\u003eTai AX, Song JC: Surgical outcomes of Baerveldt implants in pediatric glaucoma patients. Journal of AAPOS. 2014, 18:550\u0026ndash;3. 10.1016/j.jaapos.2014.08.003\u003c/li\u003e\n\u003cli\u003eBudenz DL, Sakamoto D, Eliezer R, Varma R, Heuer DK: Two-staged Baerveldt Glaucoma Implant for Childhood Glaucoma Associated with Sturge-Weber Syndrome. 2000. \u003c/li\u003e\n\u003cli\u003eEsfandiari H, Kurup SP, Torkian P, Mets MB, Rahmani B, Tanna AP: Long-term Clinical Outcomes of Ahmed and Baerveldt Drainage Device Surgery for Pediatric Glaucoma Following Cataract Surgery. J Glaucoma. 2019, 28:865\u0026ndash;70. 10.1097/IJG.0000000000001335\u003c/li\u003e\n\u003cli\u003eBanitt MR, Sidoti PA, Gentile RC, Tello C, Liebmann JM, Rodriguez N, Dhar S: Pars plana Baerveldt implantation for refractory childhood glaucomas. J Glaucoma. 2009, 18:412\u0026ndash;7. 10.1097/IJG.0b013e31818624bd\u003c/li\u003e\n\u003cli\u003eJacobson A, Besirli CG, Bohnsack BL: Outcomes of Baerveldt Glaucoma Drainage Devices in Pediatric Eyes. J Glaucoma. 2022, 31:468\u0026ndash;77. 10.1097/IJG.0000000000001970\u003c/li\u003e\n\u003cli\u003evan Overdam KA: Baerveldt glaucoma implant in paediatric patients. British Journal of Ophthalmology. 2006, 90:328\u0026ndash;32. 10.1136/bjo.2005.078832\u003c/li\u003e\n\u003cli\u003eStallworth JY, O\u0026rsquo;Brien KS, Han Y, Oatts JT: Efficacy of Ahmed and Baerveldt glaucoma drainage device implantation in the pediatric population: A systematic review and meta-analysis. Surv Ophthalmol. 2023, 68:578\u0026ndash;90. 10.1016/j.survophthal.2023.01.010\u003c/li\u003e\n\u003cli\u003eSenthil S, Turaga K, Mohammed HA, et al.: Outcomes of Silicone Ahmed Glaucoma Valve Implantation in Refractory Pediatric Glaucoma. J Glaucoma. 2018, 27:769\u0026ndash;75. 10.1097/IJG.0000000000001032\u003c/li\u003e\n\u003cli\u003eChristakis PG, Kalenak JW, Tsai JC, et al.: The Ahmed Versus Baerveldt Study. Ophthalmology. 2016, 123:2093\u0026ndash;102. 10.1016/j.ophtha.2016.06.035\u003c/li\u003e\n\u003cli\u003eBudenz DL, Barton K, Gedde SJ, et al.: Five-Year Treatment Outcomes in the Ahmed Baerveldt Comparison Study. Ophthalmology. 2015, 122:308\u0026ndash;16. 10.1016/j.ophtha.2014.08.043\u003c/li\u003e\n\u003cli\u003eMandal AK, Bagga H, Nutheti R, Gothwal VK, Nanda AK: Trabeculectomy with or without mitomycin-C for paediatric glaucoma in aphakia and pseudophakia following congenital cataract surgery. Eye. 2003, 17:53\u0026ndash;62. 10.1038/sj.eye.6700180\u003c/li\u003e\n\u003cli\u003eSimons A-S, Casteels I, Grigg J, Stalmans I, Vandewalle E, Lemmens S: Management of Childhood Glaucoma Following Cataract Surgery. J Clin Med. 2022, 11:1041. 10.3390/jcm11041041\u003c/li\u003e\n\u003cli\u003eGiampani J, Borges-Giampani AS, Carani JCE, Oltrogge EW, Susanna R: Efficacy and Safety of Trabeculectomy with Mitomycin C for Childhood Glaucoma: A Study of Results with Long-Term Follow-Up. Clinics. 2008, 63:421\u0026ndash;6. 10.1590/S1807-59322008000400002\u003c/li\u003e\n\u003cli\u003eBeck AD, Wilson WR, Lynch MG, Lynn MJ, Noe R: Trabeculectomy with adjunctive mitomycin C in pediatric glaucoma. Am J Ophthalmol. 1998, 126:648\u0026ndash;57. 10.1016/S0002-9394(98)00227-X\u003c/li\u003e\n\u003cli\u003eAktas Z, Gulpinar Ikiz GD: Current surgical techniques for the management of pediatric glaucoma: A literature review. Frontiers in Ophthalmology. 2023, 3:. 10.3389/fopht.2023.1101281\u003c/li\u003e\n\u003cli\u003eCoviltir V, Marinescu MC, Urse BM, Burcel MG: Primary Congenital and Childhood Glaucoma\u0026mdash;A Complex Clinical Picture and Surgical Management. Diagnostics. 2025, 15:308. 10.3390/diagnostics15030308\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"international-ophthalmology","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"inte","sideBox":"Learn more about [International Ophthalmology](https://www.springer.com/journal/10792)","snPcode":"10792","submissionUrl":"https://submission.nature.com/new-submission/10792/3","title":"International Ophthalmology","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false},"keywords":"Baerveldt, glaucoma, review, surgery","lastPublishedDoi":"10.21203/rs.3.rs-7821244/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-7821244/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e\u003cp\u003ePediatric glaucoma following surgery (GFS) remains a serious postoperative complication with potential for vision loss. Although glaucoma drainage devices are widely used in this setting, high-quality pooled evidence on the Baerveldt glaucoma implant (BGI) in children is limited. To systematically evaluate the efficacy and safety of BGI in pediatric patients with GFS.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e\u003cp\u003e Following PRISMA guidelines, five databases were searched up to August 2025. Eligible studies included pediatric cohorts (\u0026le;\u0026thinsp;18 years) undergoing BGI after surgery, reporting intraocular pressure (IOP) outcomes or surgical success. Data were pooled using random-effects meta-analysis.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e\u003cp\u003eFive studies (116 patients) met inclusion criteria. The mean age ranged from 3.0\u0026ndash;7.8 years, with average follow-up of 31 months. The pooled success rate of IOP control was 84.5% (95% CI 0.75\u0026ndash;0.91), with no evidence of heterogeneity. Hypotony occurred in 7.5%, choroidal effusion in 9%, and rare events included phthisis bulbi (2%), endophthalmitis (1.4%), and corneal decompensation (3.3%).\u003c/p\u003e\u003ch2\u003eConclusion\u003c/h2\u003e\u003cp\u003eBGI provides effective and relatively safe IOP control after surgery, with complication rates comparable to or lower than alternative surgical options. However, evidence is constrained by limited sample size, retrospective design, and short- to mid-term follow-up. Long-term multicenter prospective trials are warranted.\u003c/p\u003e","manuscriptTitle":"Outcomes of Baerveldt Implantation for Pediatric Glaucoma Following Surgery: A Systematic Review and Meta-Analysis","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-10-30 14:41:07","doi":"10.21203/rs.3.rs-7821244/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2025-11-01T15:01:22+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2025-11-01T14:55:20+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2025-11-01T07:01:03+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2025-10-28T14:46:59+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"127135244918329160590321900606700208337","date":"2025-10-27T07:34:16+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"141165224865896090504161307875430798655","date":"2025-10-24T09:16:21+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"190850317210162766643083274448542502176","date":"2025-10-22T19:01:26+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2025-10-17T14:45:21+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2025-10-10T09:29:28+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2025-10-10T09:26:54+00:00","index":"","fulltext":""},{"type":"submitted","content":"International Ophthalmology","date":"2025-10-09T23:48:31+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"international-ophthalmology","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"inte","sideBox":"Learn more about [International Ophthalmology](https://www.springer.com/journal/10792)","snPcode":"10792","submissionUrl":"https://submission.nature.com/new-submission/10792/3","title":"International Ophthalmology","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false}}],"origin":"","ownerIdentity":"0b1f0186-7c46-4bc3-a3ea-e62e718d1e04","owner":[],"postedDate":"October 30th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2025-12-15T16:03:40+00:00","versionOfRecord":{"articleIdentity":"rs-7821244","link":"https://doi.org/10.1007/s10792-025-03901-y","journal":{"identity":"international-ophthalmology","isVorOnly":false,"title":"International Ophthalmology"},"publishedOn":"2025-12-09 15:58:26","publishedOnDateReadable":"December 9th, 2025"},"versionCreatedAt":"2025-10-30 14:41:07","video":"","vorDoi":"10.1007/s10792-025-03901-y","vorDoiUrl":"https://doi.org/10.1007/s10792-025-03901-y","workflowStages":[]},"version":"v1","identity":"rs-7821244","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-7821244","identity":"rs-7821244","version":["v1"]},"buildId":"XKTyCvWXoU3ODBz1xrDgd","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}