Comparison of Transconjunctival and Transnasal approaches for orbital decompression: A randomized controlled trial

Comparison of Transconjunctival and Transnasal approaches for orbital decompression: A randomized controlled trial | 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 Comparison of Transconjunctival and Transnasal approaches for orbital decompression: A randomized controlled trial Rou Sun, Jing Sun, Xuefei Song, Shuo Zhang, Yinwei Li, Huifang Zhou This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-4008440/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 To compare the effectiveness of endoscopic orbital decompression by two surgical approaches for thyroid-associated ophthalmopathy (TAO). Methods A prospective, randomized controlled trial was performed on 48 moderate-to-severe or sight-threatening TAO orbits. All patients, who were randomly assigned into transconjunctival group or transnasal group, underwent endoscopic orbital decompression according to the surgical design. Clinical and radiological data were collected at baseline and 3 months after surgery by a masked investigator. The main outcome was the effective rate. If the postoperative proptosis measured by computed tomography (CT) was below 18 mm or the value of proptosis reduction was over 8 mm, it would be defined as effective. The secondary outcomes included surgical accuracy, best-corrected visual acuity (BCVA), ocular motility grade, diplopia grade, and safety. Results 48 orbits of 41 patients were enrolled in the study, with 24 orbits each in transconjunctival and transnasal group. The effective rate was 87.5% in the transconjunctival group and it was 79.2% in the transnasal group (P = 0.087). The proptosis reduction was 5.38 ± 2.60 mm in the transconjunctival group and 4.40 ± 1.66 mm in the transnasal group (P = 0.435). A significant difference was found between preoperative and postoperative proptosis in both groups (P < 0.01). In the transconjunctival group, a higher surgical accuracy in the medial wall was found (P = 0.001). There was no significant difference in both groups between preoperative and postoperative BCVA and ocular motility grade. Complications showed no significant difference between two groups (P > 0.05). Conclusion Both transconjuntival and transnasal endoscopic orbital decompression were feasible, and could be utilized by surgeons. This study was registered with Chinese clinical trial registry (Trial registration number: ChiCTR-INR-17013268; date of access and registration: November 3, 2017). thyroid-associated ophthalmopathy endoscope surgical approach Figures Figure 1 Figure 2 Introduction Thyroid-associated ophthalmopathy (TAO) is an autoimmune disease, ranking first among orbital diseases in adults. [ 1 ] Orbital decompression is an accepted treatment of reducing exophthalmos for inactive moderate-to-severe TAO patients and rehabilitating vision loss for sight-threatening TAO patients. [ 2 , 3 ] The range of orbital decompression includes the removal of lateral wall, medial wall, and inferior wall. [ 4 ] The lateral wall decompression is routinely performed percutaneously. [ 5 ] The medial wall and inferior wall are anatomically adjacent to the paranasal sinus, thus, both transconjunctival and transnasal approaches can be selected. Combined endoscopic transnasal medial and inferior orbital wall decompression done in conjunction with transcutaneous lateral orbital decompression carried a proptosis reduction of 4.2 mm. [ 6 ] Some previous studies demonstrated that transconjunctival decompression had less hypoesthesia and early sinusitis while transnasal medial wall decompression had a better postoperative best corrected visual acuity (BCVA). [ 7 – 9 ] However, these are retrospective studies, and stronger evidence is required. Therefore, we conducted a prospective, randomized controlled trial (RCT) to compare the effectiveness, accuracy, and safety of two surgical approaches. Materials and methods Study design This was a prospective, randomized, single-center clinical trial. The study was approved by the ethics committee of the Ninth People's Hospital and conducted according to the tenets of the Declaration of Helsinki. Written informed consent was obtained from all patients prior to enrollment. Patients were recruited from the Department of Ophthalmology of the Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (Shanghai, China), from November, 2017 to November, 2020. Patients Patients who aged older than 18 years old and were diagnosed with inactive moderate-to-severe TAO or sight-threatening TAO with a proptosis over 18 mm were included. Patients with severe heart, liver and kidney dysfunction, uncontrolled diabetes, hypertension and psychosis, or pregnant or lactating women were excluded. Randomization A random number seed was used by R programming language to calculate the next number in a sequence. The envelope method was used to assign and hide the allocation sequence, and patients' enrollment was judged using a random number table. Statisticians and clinical evaluation doctors were blind to grouping. Baseline and follow-up measures Two clinical visits were performed at baseline and 12 ± 1 weeks after surgery. The primary outcome measure was the effective rate. If the postoperative proptosis measured by computed tomography (CT) was below 18 mm or the value of proptosis reduction was over 8 mm, it would be defined as effective. Proptosis The value of proptosis was measured by CT. The distance between the surface of cornea and the orbital rim after reconstruction was measured. [ 10 ] The secondary outcome measures included the evaluation of surgical accuracy, BCVA, ocular motility grade, diplopia grade, and safety. Surgical accuracy The surgical accuracy was defined as the ratio of the actual area of orbital wall removed after the surgery to the preoperative designed area of orbital wall to be removed. The measurement was completed on 3-matic Research 8.0 software. BCVA The BCVA was measured by the international standard visual acuity chart. Ocular motility grade The eye movement was evaluated in four directions. It could be defined as four grades according to the range of motion (0 ≥ 45°, 1 = 30–45°, 2 = 15–30°, and 3 ≤ 15°). [ 3 ] Diplopia grade Grade 0, indicating no diplopia was observed. A participant with peripheral diplopia would achieve grade 1, while participants with intermittent central diplopia and persistent central diplopia would achieve grades 2 and 3, respectively. [ 4 ] Safety The complications were recorded during or after surgery. Surgical technique The preoperative plan was designed with the EndoNavi 2.0 system (UEG Co., Ltd., Shanghai, China). The preoperative surgical design was carried out according to the value of proptosis, based on the principle proposed by Kikkawa. [ 11 , 12 ] All the surgeries were were performed by the same surgeon (Z.H.) with the endoscope-navigation system (ENS) (UEG Co., Ltd., Shanghai, China). Orbital decompression Lateral wall decompression The surgical method was the same in both groups with a double eyelid incision. The range of the lateral wall from orbital roof to infraorbital fissure on the coronal plane and from medial skull base to orbital rim on the axial plane was removed with power saw and cutting burr. The periosteum of the lateral orbit was incised, and fat was allowed to prolapse into the newly created space. Medial wall decompression Transconjunctival group A transcaruncular incision was made followed by a blunt dissection medially toward the posterior lacrimal crest. The periorbita was then elevated off the medial wall with a Freer elevator. The ethmoid bone was removed posteriorly with a suction tip and Takahashi forceps according to the preoperative design. The periorbita was opened in a posterior to anterior direction, thus allowing the protrusion of orbital fat in the newly opened spaces. Transnasal group After the uncinate process was incised and removed, the ethmoidal bulla was resected, and an ethmoidectomy was performed. [ 13 ] The ethmoidal air cells were opened and subsequently removed up to the cribriform plate. The lamina papyracea was then completely exposed. The lamina papyracea was then infractured with a blunt-tipped seeker and removed in pieces, exposing the periorbita. Two horizontal incisions were made in the periorbita to allow prolapse of orbital fat into the ethmoid cavity. Inferior wall decompression Transconjunctival group After a transconjunctival incision was made, the infraorbital margin was exposed and the periosteum was cut 2 mm below the infraorbital margin. After the periosteum was elevated by freer, the orbital floor was resected by rongeur or puncher. The periorbita was incised to allow the protrusion of orbital fat into the maxillary cavity. Transnasal group An incision was made in the nasal vestibule to reach the surgical region by the prelacrimal recess approach. [ 14 , 15 ] The maxillary sinus roof wall was grinded by a diamond burr, then infractured with a freer and removed in pieces, exposing the periorbita. The periorbita was incised to allow prolapse of orbital fat into the maxillary sinus. Statistical analysis Statistical analysis was performed using R 4.0.1 programming language. P ≤ 0.05 was considered statistically significant. According to the character of the data, paired t-test, Wilcoxon signed-rank test, Wilcoxon rank-sum test, Chi-square test or a nonparametric test were employed. For the missing endpoint indicators, the last observation carried forward method was used to fill in the missing values. If there was an imbalance in the baseline data between the two groups, the multivariate logistic regression analysis was used to correct the imbalance index in the study endpoint analysis. Results Baseline characteristics: In total, 48 orbits from 41 patients were included between November 2017 and November 2020(Fig. 1 ). The comparison of preoperative baseline characteristics between the two groups showed no significant difference except for age (Table 1). Therefore, the multivariate logistic regression analysis was used. Effective rate The effective rate was 87.5% in the transconjunctival group and 79.2% in the transnasal group (P = 0.087). In the transconjunctival group, 6 orbits (25%) proptosis regressed over 8 mm, and 20 orbits (83.3%) proptosis regressed to less than 18 mm, while 0 (0%) and 19 orbits (79.2%) in the transnasal group respectively. A significant difference was found between preoperative and postoperative proptosis in both groups (P < 0.001). The mean proptosis reduction in the transconjunctival group was 5.38 ± 2.60 mm, while it was 4.40 ± 1.66 mm in the transnasal group (P = 0.435, Table 2). Surgical accuracy The surgical accuracy of the medial wall was 94% in the transconjunctival group and 89% in the transnasal group (P = 0.001, Table 2). Besides, P-value in the inferior wall between the two groups was 0.149, and it was 0.631 in the lateral wall between the two groups. BCVA In both transconjunctival and transnasal groups, no significant difference appeared between preoperative and postoperative BCVA (P = 0.164 and 0.060, respectively). Ocular motility grade In the transconjunctival and transnasal groups, the postoperative ocular motility grade did not significantly vary (P = 0.491 and 0.110, respectively). There was no significant difference in the improvement rate and deterioration rate of the ocular motility grade between the two groups (P = 0.108 and 0.342, respectively, Table 2). Diplopia grade As diplopia is caused by simultaneous vision of both eyes, we excluded the data of two patients with two eyes divided into different groups and merged the data of five patients with two eyes divided into the same group to reduce the interference between groups. Therefore, we analyzed 20 patients in the transconjunctival group and 19 patients in the transnasal group. In the transconjunctival group, diplopia grade increased postoperatively (P = 0.049). There was no significant difference in the deterioration rate of diplopia grade between the two groups (P = 0.706, Table 2) and in the improvement rate (P = 0.082, Table 2). In addition, 4 patients in the transconjunctival group and 5 patients in the transnasal group had new-onset diplopia (P = 0.888). Complications In the transconjunctival group, only one patient experienced periorbital numbness postoperatively, and 4 patients complained about orbital pain, and one patient had foreign body sensation. In the transnasal group, 5 patients experienced periorbital numbness, 4 patients complained about orbital pain, one patient had paranasal sinusitis, and postoperative infection was found in one patient. Discussion Orbital decompression can solve the problems of exophthalmos, exposure keratitis, and compressive optic neuropathy caused by TAO. Transconjunctival approach is the most common approach with hidden incision and direct vision of surgical field. [ 12 , 16 ] However, exposure of the orbital apex tissue by using malleable retractor may lead to the increase of orbital pressure. Complications include conjunctival edema, infraorbital nerve paralysis, and cerebrospinal fluid (CSF) leak. [ 17 , 18 ] Transnasal approach takes the advantages of parasinus to reach the medial and inferior wall. The application of an endoscope provides a magnified and clear view of the surgical field. [ 19 , 20 ] However, a long learning curve is necessary to master endoscopic techniques. Complications include sinusitis, nasolacrimal duct injury and CSF leak. [ 21 , 22 ] In our study, we compared the effectiveness of orbital decompression by two surgical approaches. We utilized the effective rate as the main outcome instead of proptosis reduction. That was because surgical efficacy should be judged by whether the patient had the normal proptosis after surgery. Similarly, patients with glaucoma should control their intraocular pressure to the target level. [ 23 ] The mean proptosis was 15.89–16.24 mm in healthy Asian individuals. [ 24 , 25 ] Therefore, we assumed 18 mm as normal, allowing an increase of 2 mm. Besides, some patients have a proptosis over 25 mm and their proptosis may not be below 18 mm even after a successful three-wall orbital decompression surgery. In Kikkawa et al.’s study, such patients had a mean proptosis reduction of 8.9 ± 3.4 mm. [ 11 ] Therefore, when the proptosis was below 18 mm or reached the proptosis reduction of 8 mm, it could indicate a successful surgery. In our study, both transconjunctival and transnasal orbital decompression approaches had high effective rates of 87.5% and 79.2%, respectively, and effectively reduced proptosis (Fig. 2 ). In previous studies, the proptosis reduction could reach 2.5–8.5 mm in conventional orbital decompression via these two approaches. [ 12 , 17 , 18 ] With a navigation system, the proptosis reduction could reach 3.0-7.5 mm. [ 26 – 28 ] Nowadays, to reduce the lateral wall decompression has noticeably attracted scholars’ attention because of the low occurrence rate of postoperative diplopia and strabismus. [ 29 ] In Valerie et al.’s study, the removal of the medial and inferior walls provided a proptosis reduction of 3.9 mm, while the three-wall decompression reduced proptosis by 7.6 mm, [ 30 ] indicating that the removal of lateral wall had a great influence on the value of proptosis reduction. In the present study, 16 of 22 patients in the transconjunctival group and 21 of 24 patients in the transnasal group experienced the removal of lateral wall (P = 0.276). In addition, the surgical accuracy of the lateral wall did not significantly differ between the two groups. Therefore, we assumed that the removal of the lateral wall in our study might not influence our conclusion. In our study, the mean proptosis reduction was 5.38 mm in the transconjunctival group and 4.40 mm in the transnasal group. The difference in proptosis reduction might be related to the greater surgical accuracy in the medial wall and inferior wall decompression in the transconjunctival group. In our study, the surgical accuracy of the medial wall decompression was found higher in the transconjunctival group than the transnasal group. We speculated that although the posterior 2/3 of the medial wall (near the orbital apex) could be clearly observed in the transnasal group, the anterior 1/3 of the medial wall was difficult to remove with the endoscope angle of 0 °, which could be corresponded anatomically to the agger nasi cell. [ 31 ] Besides, only 2 patients in the transnasal group and 6 in the transconjunctival group underwent the inferior wall decompression with the surgical accuracy of 57% and 88%, which was a too small sample size to reach a robust conclusion. We found that the preoperative and postoperative BCVA did not significantly differ in the two groups. This might be related to the fact that moderate-to-severe TAO patients without vision loss had the highest proportion in our study (Table 1). No significant difference was found in the ocular motility grade between the two groups. However, patients in the transconjunctival group had a worse diplopia grade after surgery. In Dubin et al.’s study, endoscopic orbital decompression with navigation caused the new-onset diplopia of 66.7%. [ 32 ] In studies that employed transnasal decompression without navigation, the new-onset diplopia rate could reach 50–100% [ 14 , 15 ] . There are several factors that may influence new-onset diplopia, such as decompression range, the enlargement of extraocular muscles, and orbital compliance. [ 33 , 34 ] In our study, we assumed that the transconjunctival approach might remove the medial wall to a greater extent that allowed the enlarged medial rectus muscle and retrobulbar fat to form hernia in ethmoid sinus. It was resulted in the displacement of medial rectus muscle, increasing the risk of esotropia and diplopia. Therefore, we concentrated on the anterior 1/3 of the medial wall. This region might be important to prevent the displacement of eyeball, avoiding the appearance or deterioration of diplopia, which was mentioned in Wu et al.’s research. [ 35 ] The anterior 1/3 of the medial wall could be considered to preserve for patients with obvious hypertrophic medial rectus muscle or preoperative esotropia. We hypothesized that keeping the anterior 1/3 of the medial wall might be an appropriate choice for the orbital decompression. Finally, the safety of orbital decompression via both approaches was confirmed. Only one patient in the transnasal group experienced postoperative infection and was treated after surgery. There were some limitations in our study. First, this was a single-center study with a small simple size. The randomization was not perfect in age. Second, a 12-month follow-up after surgery might result in more reliable and stable results. No subjective index included in the study was a pity. In addition, layered analysis would be carried out in the future study, which would lead to a more precise conclusion for the improvement of BCVA and the surgical accuracy of the inferior wall. Conclusions In summary, endoscopic orbital decompression can effectively reduce proptosis with a promising safety. Both transconjuntival and transnasal approaches can be utilized by surgeons. Abbreviations TAO Thyroid-associated ophthalmopathy CT Computed tomography BCVA Best-corrected visual acuity RCT Randomized controlled trial ENS Endoscope-navigation system CSF Cerebrospinal fluid Declarations Acknowledgements: Not Applicable Authors’ contributions: Conceptualization, R.S., YW.L. and HF.Z.; methodology, R.S., YW.L. and HF.Z.; validation, R.S., HF.Z.; investigation, R.S., J.S., HF.Z. and YW.L.; resources, HF.Z.; data analysis, R.S. and J.S., HF.Z., YW.L.; writing—original draft, R.S.; writing—review and editing, J.S., YW.L., HF.Z., XF.S, S.Z.; visualization, R.S. and J.S.; supervision, R.S., HF.Z., and YW.L.; funding acquisition, HF.Z.. All authors have read and agreed to the published version of the manuscript. Funding: Clinical research booster program of the Ninth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine (JYLJ036); Shanghai Key Clinical Specialty; Shanghai Eye Disease Research Center (2022ZZ01003) Competing interests: None declared. Availability of data and materials: The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request. Ethics approval and consent to participate: Ethical approval was obtained for this study by the local ethics committee. References Smith TJ, Hegedus L. Graves' Disease. N Engl J Med. 2016;375(16):1552–65. Bartalena L, Baldeschi L, Boboridis K, Eckstein A, Kahaly GJ, Marcocci C, et al. The 2016 European thyroid association/European group on Graves' orbitopathy guidelines for the management of Graves' orbitopathy. Eur Thyroid J. 2016;5(1):9–26. Barrio-Barrio J, Sabater AL, Bonet-Farriol E, Velázquez-Villoria Á, Galofré JC. 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Tables Table.1 Baseline characteristics of study participants Index Total Transconjunctival group Transnasal group P Male 23 10 13 0.386 Female 25 14 11 Age y, Mean±SD 38.02±11.81 42.67 ±14.52 33.38±5.42 0.005 Moderate-to-severe 42 19 23 0.081 Sight-threatening 6 5 1 CAS 1.00 [0.00, 2.00] 1.00 [1.00, 2.00] 1.00 [0.00, 1.00] 0.122 Right 22 12 10 0.562 Left 26 12 14 Smoking history 13 5 7 0.505 No Smoking history 35 19 17 Proptosis mm，Mean±SD 21.20±2.16 21.42±2.40 20.97±1.91 0.478 Visual acuity logMAR, M [P25,P75] 0.14±0.27 0.19±0.32 0.09±0.21 0.214 Ocular motility grade M [P25,P75] 1.10±0.75 1.29±0.75 0.92±0.72 0.083 Diplopia grade M [P25,P75] 0.82±1.05 1.00±1.03 0.63±1.07 0.278 Mean±SD = mean±standard deviation M [P25,P75] = median [interquartile interval]. logMAR = logarithm to the minimal angle of resolution Table.2 Comparison table of transconjunctival and transnasal group Index Total Transconjunctival group Transnasal group P Proptosis reduction mm，Mean±SD 4.89±2.21 5.38±2.60 4.40±1.66 0.435 Vision improved, n 14 8 6 0.671 Ocular motility grade decreased, n 8 5 3 0.108 Ocular motility grade increased, n 11 3 8 0.342 Diplopia grade decreased, n 5 1 4 0.082 Diplopia grade increased, n 12 6 6 0.706 New-onset diplopia, n 9 4 5 0.888 Medial wall accuracy M [P25,P75] 0.92 [0.87, 0.94]， n=46 0.94 [0.92, 0.97]， n=22 0.89 [0.82, 0.92]， n=24 0.001 Inferior wall accuracy M [P25,P75] 0.79[0.63, 0.91]， n=8 0.88 [0.75, 0.91]， n=6 0.57 [0.53, 0.62]， n=2 0.149 Lateral wall accuracy M [P25,P75] 0.90 [0.83, 0.91]， n=37 0.91 [0.88, 0.91]， n=16 0.88 [0.83, 0.92]， n=21 0.631 Mean±SD = mean±standard deviation M [P25,P75] = median [interquartile interval]. 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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-4008440","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":276881724,"identity":"bce2d3c7-c4ae-44ac-b7af-bb50f6d73b33","order_by":0,"name":"Rou Sun","email":"","orcid":"","institution":"Ninth People’s Hospital, Shanghai Jiao Tong University","correspondingAuthor":false,"prefix":"","firstName":"Rou","middleName":"","lastName":"Sun","suffix":""},{"id":276881725,"identity":"17ebe926-c916-42ab-b4ed-4064eee3874d","order_by":1,"name":"Jing Sun","email":"","orcid":"","institution":"Ninth People’s Hospital, Shanghai Jiao Tong University","correspondingAuthor":false,"prefix":"","firstName":"Jing","middleName":"","lastName":"Sun","suffix":""},{"id":276881726,"identity":"bad12a5a-8801-4632-aa8f-5f77a1314b96","order_by":2,"name":"Xuefei Song","email":"","orcid":"","institution":"Ninth People’s Hospital, Shanghai Jiao Tong University","correspondingAuthor":false,"prefix":"","firstName":"Xuefei","middleName":"","lastName":"Song","suffix":""},{"id":276881727,"identity":"6fd348e5-f827-4afc-85d4-1bde13e84a83","order_by":3,"name":"Shuo Zhang","email":"","orcid":"","institution":"Ninth People’s Hospital, Shanghai Jiao Tong University","correspondingAuthor":false,"prefix":"","firstName":"Shuo","middleName":"","lastName":"Zhang","suffix":""},{"id":276881728,"identity":"1d376ae4-6034-4e79-afc6-dc715540b63a","order_by":4,"name":"Yinwei Li","email":"","orcid":"","institution":"Ninth People’s Hospital, Shanghai Jiao Tong University","correspondingAuthor":false,"prefix":"","firstName":"Yinwei","middleName":"","lastName":"Li","suffix":""},{"id":276881729,"identity":"5ddb2244-54d5-4a47-a398-b4fa057a39f8","order_by":5,"name":"Huifang Zhou","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAABAUlEQVRIiWNgGAWjYBAC9gYwJQfEzAcYJMCcBPxaeA6AKWMgZktgkEggTQuPAVQ1IS3sZw+//PHHQN6cf83nD5Y/DjPws+cYMPzcgUcLT16ahQSPgeHOGW+3SUgkHGaQ7HljwNh7BrcWe4YcMwMDiT+MG26c3cYA0mJwI8eAmbENjy38b8wMEgwM7DfcOPP4A0iLPUEtEjnGDw4kGCRuON/DAHaYgQRBLW/MGBsOGCRvuMFmJiGRls4jceZZwcFevA7LMf4IDDHbDecPP/4sYWMtx9+evPHBTzxagIANEufAaGQGsnhA7AN4NQATygcwxX+AgfEDAaWjYBSMglEwMgEAyQxRE//uR1MAAAAASUVORK5CYII=","orcid":"","institution":"Ninth People’s Hospital, Shanghai Jiao Tong University","correspondingAuthor":true,"prefix":"","firstName":"Huifang","middleName":"","lastName":"Zhou","suffix":""}],"badges":[],"createdAt":"2024-03-03 11:37:34","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-4008440/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-4008440/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":52452753,"identity":"c88a0ae2-55c2-43af-aac3-3da0a9102b4e","added_by":"auto","created_at":"2024-03-11 19:17:38","extension":"jpg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":86786,"visible":true,"origin":"","legend":"\u003cp\u003eFlow chart of the study\u003c/p\u003e","description":"","filename":"Figure1.jpg","url":"https://assets-eu.researchsquare.com/files/rs-4008440/v1/0d5366253c931a81807bd6b4.jpg"},{"id":52452801,"identity":"66ba40c9-49d7-4b0b-922f-9892c23bf01b","added_by":"auto","created_at":"2024-03-11 19:17:48","extension":"jpg","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":160831,"visible":true,"origin":"","legend":"\u003cp\u003eTypical cases (1-A, 1-B) The preoperative and postoperative threedimensional reconstruction images, horizontal images and coronal images of the patient in transconjunctival group; (2-A, 2-B) The preoperative and postoperative threedimensional reconstruction images, horizontal images and coronal images of the patient in transnasal group\u003c/p\u003e","description":"","filename":"Figure2.jpg","url":"https://assets-eu.researchsquare.com/files/rs-4008440/v1/0874de85cd61cc5f173d8761.jpg"},{"id":52770938,"identity":"fefeefe5-f63c-4e8b-8666-67c88b077a54","added_by":"auto","created_at":"2024-03-15 14:37:16","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":363548,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-4008440/v1/5ac5ee12-6a3b-459b-a8ee-384fb0b14c2f.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Comparison of Transconjunctival and Transnasal approaches for orbital decompression: A randomized controlled trial","fulltext":[{"header":"Introduction","content":"\u003cp\u003eThyroid-associated ophthalmopathy (TAO) is an autoimmune disease, ranking first among orbital diseases in adults. \u003csup\u003e[\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]\u003c/sup\u003e Orbital decompression is an accepted treatment of reducing exophthalmos for inactive moderate-to-severe TAO patients and rehabilitating vision loss for sight-threatening TAO patients.\u003csup\u003e[\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e, \u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e]\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eThe range of orbital decompression includes the removal of lateral wall, medial wall, and inferior wall.\u003csup\u003e[\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e]\u003c/sup\u003e The lateral wall decompression is routinely performed percutaneously.\u003csup\u003e[\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]\u003c/sup\u003e The medial wall and inferior wall are anatomically adjacent to the paranasal sinus, thus, both transconjunctival and transnasal approaches can be selected. Combined endoscopic transnasal medial and inferior orbital wall decompression done in conjunction with transcutaneous lateral orbital decompression carried a proptosis reduction of 4.2 mm.\u003csup\u003e[\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]\u003c/sup\u003e Some previous studies demonstrated that transconjunctival decompression had less hypoesthesia and early sinusitis while transnasal medial wall decompression had a better postoperative best corrected visual acuity (BCVA).\u003csup\u003e[\u003cspan additionalcitationids=\"CR8\" citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e]\u003c/sup\u003e However, these are retrospective studies, and stronger evidence is required. Therefore, we conducted a prospective, randomized controlled trial (RCT) to compare the effectiveness, accuracy, and safety of two surgical approaches.\u003c/p\u003e"},{"header":"Materials and methods","content":"\u003cp\u003eStudy design\u003c/p\u003e \u003cp\u003eThis was a prospective, randomized, single-center clinical trial. The study was approved by the ethics committee of the Ninth People's Hospital and conducted according to the tenets of the Declaration of Helsinki. Written informed consent was obtained from all patients prior to enrollment. Patients were recruited from the Department of Ophthalmology of the Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (Shanghai, China), from November, 2017 to November, 2020.\u003c/p\u003e \u003cp\u003ePatients\u003c/p\u003e \u003cp\u003ePatients who aged older than 18 years old and were diagnosed with inactive moderate-to-severe TAO or sight-threatening TAO with a proptosis over 18 mm were included. Patients with severe heart, liver and kidney dysfunction, uncontrolled diabetes, hypertension and psychosis, or pregnant or lactating women were excluded.\u003c/p\u003e \u003cp\u003eRandomization\u003c/p\u003e \u003cp\u003eA random number seed was used by R programming language to calculate the next number in a sequence. The envelope method was used to assign and hide the allocation sequence, and patients' enrollment was judged using a random number table. Statisticians and clinical evaluation doctors were blind to grouping.\u003c/p\u003e \u003cp\u003eBaseline and follow-up measures\u003c/p\u003e \u003cp\u003eTwo clinical visits were performed at baseline and 12\u0026thinsp;\u0026plusmn;\u0026thinsp;1 weeks after surgery.\u003c/p\u003e \u003cp\u003eThe primary outcome measure was the effective rate. If the postoperative proptosis measured by computed tomography (CT) was below 18 mm or the value of proptosis reduction was over 8 mm, it would be defined as effective.\u003c/p\u003e \u003cp\u003eProptosis\u003c/p\u003e \u003cp\u003eThe value of proptosis was measured by CT. The distance between the surface of cornea and the orbital rim after reconstruction was measured.\u003csup\u003e[\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e]\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eThe secondary outcome measures included the evaluation of surgical accuracy, BCVA, ocular motility grade, diplopia grade, and safety.\u003c/p\u003e \u003cp\u003eSurgical accuracy\u003c/p\u003e \u003cp\u003eThe surgical accuracy was defined as the ratio of the actual area of orbital wall removed after the surgery to the preoperative designed area of orbital wall to be removed. The measurement was completed on 3-matic Research 8.0 software.\u003c/p\u003e\n\u003ch3\u003eBCVA\u003c/h3\u003e\n\u003cp\u003eThe BCVA was measured by the international standard visual acuity chart.\u003c/p\u003e \u003cp\u003eOcular motility grade\u003c/p\u003e \u003cp\u003eThe eye movement was evaluated in four directions. It could be defined as four grades according to the range of motion (0\u0026thinsp;\u0026ge;\u0026thinsp;45\u0026deg;, 1\u0026thinsp;=\u0026thinsp;30\u0026ndash;45\u0026deg;, 2\u0026thinsp;=\u0026thinsp;15\u0026ndash;30\u0026deg;, and 3\u0026thinsp;\u0026le;\u0026thinsp;15\u0026deg;).\u003csup\u003e[\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e]\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eDiplopia grade\u003c/p\u003e \u003cp\u003eGrade 0, indicating no diplopia was observed. A participant with peripheral diplopia would achieve grade 1, while participants with intermittent central diplopia and persistent central diplopia would achieve grades 2 and 3, respectively.\u003csup\u003e[\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e]\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eSafety\u003c/p\u003e \u003cp\u003eThe complications were recorded during or after surgery.\u003c/p\u003e \u003cp\u003eSurgical technique\u003c/p\u003e \u003cp\u003eThe preoperative plan was designed with the EndoNavi 2.0 system (UEG Co., Ltd., Shanghai, China). The preoperative surgical design was carried out according to the value of proptosis, based on the principle proposed by Kikkawa.\u003csup\u003e[\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e, \u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e]\u003c/sup\u003e All the surgeries were were performed by the same surgeon (Z.H.) with the endoscope-navigation system (ENS) (UEG Co., Ltd., Shanghai, China).\u003c/p\u003e \u003cp\u003eOrbital decompression\u003c/p\u003e \u003cp\u003eLateral wall decompression\u003c/p\u003e \u003cp\u003eThe surgical method was the same in both groups with a double eyelid incision. The range of the lateral wall from orbital roof to infraorbital fissure on the coronal plane and from medial skull base to orbital rim on the axial plane was removed with power saw and cutting burr. The periosteum of the lateral orbit was incised, and fat was allowed to prolapse into the newly created space.\u003c/p\u003e \u003cp\u003eMedial wall decompression\u003c/p\u003e \u003cp\u003eTransconjunctival group\u003c/p\u003e \u003cp\u003eA transcaruncular incision was made followed by a blunt dissection medially toward the posterior lacrimal crest. The periorbita was then elevated off the medial wall with a Freer elevator. The ethmoid bone was removed posteriorly with a suction tip and Takahashi forceps according to the preoperative design. The periorbita was opened in a posterior to anterior direction, thus allowing the protrusion of orbital fat in the newly opened spaces.\u003c/p\u003e \u003cp\u003eTransnasal group\u003c/p\u003e \u003cp\u003eAfter the uncinate process was incised and removed, the ethmoidal bulla was resected, and an ethmoidectomy was performed.\u003csup\u003e[\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e]\u003c/sup\u003e The ethmoidal air cells were opened and subsequently removed up to the cribriform plate. The lamina papyracea was then completely exposed. The lamina papyracea was then infractured with a blunt-tipped seeker and removed in pieces, exposing the periorbita. Two horizontal incisions were made in the periorbita to allow prolapse of orbital fat into the ethmoid cavity.\u003c/p\u003e \u003cp\u003eInferior wall decompression\u003c/p\u003e \u003cp\u003eTransconjunctival group\u003c/p\u003e \u003cp\u003eAfter a transconjunctival incision was made, the infraorbital margin was exposed and the periosteum was cut 2 mm below the infraorbital margin. After the periosteum was elevated by freer, the orbital floor was resected by rongeur or puncher. The periorbita was incised to allow the protrusion of orbital fat into the maxillary cavity.\u003c/p\u003e \u003cp\u003eTransnasal group\u003c/p\u003e \u003cp\u003eAn incision was made in the nasal vestibule to reach the surgical region by the prelacrimal recess approach. \u003csup\u003e[\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e, \u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e]\u003c/sup\u003e The maxillary sinus roof wall was grinded by a diamond burr, then infractured with a freer and removed in pieces, exposing the periorbita. The periorbita was incised to allow prolapse of orbital fat into the maxillary sinus.\u003c/p\u003e \u003cdiv id=\"Sec4\" class=\"Section2\"\u003e \u003ch2\u003eStatistical analysis\u003c/h2\u003e \u003cp\u003eStatistical analysis was performed using R 4.0.1 programming language. P\u0026thinsp;\u0026le;\u0026thinsp;0.05 was considered statistically significant. According to the character of the data, paired t-test, Wilcoxon signed-rank test, Wilcoxon rank-sum test, Chi-square test or a nonparametric test were employed. For the missing endpoint indicators, the last observation carried forward method was used to fill in the missing values. If there was an imbalance in the baseline data between the two groups, the multivariate logistic regression analysis was used to correct the imbalance index in the study endpoint analysis.\u003c/p\u003e \u003c/div\u003e"},{"header":"Results","content":"\u003cp\u003eBaseline characteristics: In total, 48 orbits from 41 patients were included between November 2017 and November 2020(Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e). The comparison of preoperative baseline characteristics between the two groups showed no significant difference except for age (Table\u0026nbsp;1). Therefore, the multivariate logistic regression analysis was used.\u003c/p\u003e\u003cp\u003eEffective rate\u003c/p\u003e \u003cp\u003eThe effective rate was 87.5% in the transconjunctival group and 79.2% in the transnasal group (P\u0026thinsp;=\u0026thinsp;0.087). In the transconjunctival group, 6 orbits (25%) proptosis regressed over 8 mm, and 20 orbits (83.3%) proptosis regressed to less than 18 mm, while 0 (0%) and 19 orbits (79.2%) in the transnasal group respectively. A significant difference was found between preoperative and postoperative proptosis in both groups (P\u0026thinsp;\u0026lt;\u0026thinsp;0.001). The mean proptosis reduction in the transconjunctival group was 5.38\u0026thinsp;\u0026plusmn;\u0026thinsp;2.60 mm, while it was 4.40\u0026thinsp;\u0026plusmn;\u0026thinsp;1.66 mm in the transnasal group (P\u0026thinsp;=\u0026thinsp;0.435, Table\u0026nbsp;2).\u003c/p\u003e \u003cp\u003eSurgical accuracy\u003c/p\u003e \u003cp\u003eThe surgical accuracy of the medial wall was 94% in the transconjunctival group and 89% in the transnasal group (P\u0026thinsp;=\u0026thinsp;0.001, Table\u0026nbsp;2). Besides, P-value in the inferior wall between the two groups was 0.149, and it was 0.631 in the lateral wall between the two groups.\u003c/p\u003e\n\u003ch3\u003eBCVA\u003c/h3\u003e\n\u003cp\u003eIn both transconjunctival and transnasal groups, no significant difference appeared between preoperative and postoperative BCVA (P\u0026thinsp;=\u0026thinsp;0.164 and 0.060, respectively).\u003c/p\u003e \u003cp\u003eOcular motility grade\u003c/p\u003e \u003cp\u003eIn the transconjunctival and transnasal groups, the postoperative ocular motility grade did not significantly vary (P\u0026thinsp;=\u0026thinsp;0.491 and 0.110, respectively). There was no significant difference in the improvement rate and deterioration rate of the ocular motility grade between the two groups (P\u0026thinsp;=\u0026thinsp;0.108 and 0.342, respectively, Table\u0026nbsp;2).\u003c/p\u003e \u003cp\u003eDiplopia grade\u003c/p\u003e \u003cp\u003eAs diplopia is caused by simultaneous vision of both eyes, we excluded the data of two patients with two eyes divided into different groups and merged the data of five patients with two eyes divided into the same group to reduce the interference between groups. Therefore, we analyzed 20 patients in the transconjunctival group and 19 patients in the transnasal group. In the transconjunctival group, diplopia grade increased postoperatively (P\u0026thinsp;=\u0026thinsp;0.049). There was no significant difference in the deterioration rate of diplopia grade between the two groups (P\u0026thinsp;=\u0026thinsp;0.706, Table\u0026nbsp;2) and in the improvement rate (P\u0026thinsp;=\u0026thinsp;0.082, Table\u0026nbsp;2). In addition, 4 patients in the transconjunctival group and 5 patients in the transnasal group had new-onset diplopia (P\u0026thinsp;=\u0026thinsp;0.888).\u003c/p\u003e \u003cp\u003eComplications\u003c/p\u003e \u003cp\u003eIn the transconjunctival group, only one patient experienced periorbital numbness postoperatively, and 4 patients complained about orbital pain, and one patient had foreign body sensation. In the transnasal group, 5 patients experienced periorbital numbness, 4 patients complained about orbital pain, one patient had paranasal sinusitis, and postoperative infection was found in one patient.\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eOrbital decompression can solve the problems of exophthalmos, exposure keratitis, and compressive optic neuropathy caused by TAO. Transconjunctival approach is the most common approach with hidden incision and direct vision of surgical field.\u003csup\u003e[\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e, \u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e]\u003c/sup\u003e However, exposure of the orbital apex tissue by using malleable retractor may lead to the increase of orbital pressure. Complications include conjunctival edema, infraorbital nerve paralysis, and cerebrospinal fluid (CSF) leak.\u003csup\u003e[\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e, \u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e]\u003c/sup\u003e Transnasal approach takes the advantages of parasinus to reach the medial and inferior wall. The application of an endoscope provides a magnified and clear view of the surgical field.\u003csup\u003e[\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e, \u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e]\u003c/sup\u003e However, a long learning curve is necessary to master endoscopic techniques. Complications include sinusitis, nasolacrimal duct injury and CSF leak.\u003csup\u003e[\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e, \u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e]\u003c/sup\u003e In our study, we compared the effectiveness of orbital decompression by two surgical approaches.\u003c/p\u003e \u003cp\u003eWe utilized the effective rate as the main outcome instead of proptosis reduction. That was because surgical efficacy should be judged by whether the patient had the normal proptosis after surgery. Similarly, patients with glaucoma should control their intraocular pressure to the target level.\u003csup\u003e[\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e]\u003c/sup\u003e The mean proptosis was 15.89\u0026ndash;16.24 mm in healthy Asian individuals.\u003csup\u003e[\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e, \u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e]\u003c/sup\u003e Therefore, we assumed 18 mm as normal, allowing an increase of 2 mm. Besides, some patients have a proptosis over 25 mm and their proptosis may not be below 18 mm even after a successful three-wall orbital decompression surgery. In Kikkawa et al.\u0026rsquo;s study, such patients had a mean proptosis reduction of 8.9\u0026thinsp;\u0026plusmn;\u0026thinsp;3.4 mm.\u003csup\u003e[\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e]\u003c/sup\u003e Therefore, when the proptosis was below 18 mm or reached the proptosis reduction of 8 mm, it could indicate a successful surgery.\u003c/p\u003e \u003cp\u003eIn our study, both transconjunctival and transnasal orbital decompression approaches had high effective rates of 87.5% and 79.2%, respectively, and effectively reduced proptosis (Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e). In previous studies, the proptosis reduction could reach 2.5\u0026ndash;8.5 mm in conventional orbital decompression via these two approaches.\u003csup\u003e[\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e, \u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e, \u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e]\u003c/sup\u003e With a navigation system, the proptosis reduction could reach 3.0-7.5 mm.\u003csup\u003e[\u003cspan additionalcitationids=\"CR27\" citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e]\u003c/sup\u003e Nowadays, to reduce the lateral wall decompression has noticeably attracted scholars\u0026rsquo; attention because of the low occurrence rate of postoperative diplopia and strabismus.\u003csup\u003e[\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e]\u003c/sup\u003e In Valerie et al.\u0026rsquo;s study, the removal of the medial and inferior walls provided a proptosis reduction of 3.9 mm, while the three-wall decompression reduced proptosis by 7.6 mm,\u003csup\u003e[\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e]\u003c/sup\u003e indicating that the removal of lateral wall had a great influence on the value of proptosis reduction. In the present study, 16 of 22 patients in the transconjunctival group and 21 of 24 patients in the transnasal group experienced the removal of lateral wall (P\u0026thinsp;=\u0026thinsp;0.276). In addition, the surgical accuracy of the lateral wall did not significantly differ between the two groups. Therefore, we assumed that the removal of the lateral wall in our study might not influence our conclusion. In our study, the mean proptosis reduction was 5.38 mm in the transconjunctival group and 4.40 mm in the transnasal group. The difference in proptosis reduction might be related to the greater surgical accuracy in the medial wall and inferior wall decompression in the transconjunctival group.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003eIn our study, the surgical accuracy of the medial wall decompression was found higher in the transconjunctival group than the transnasal group. We speculated that although the posterior 2/3 of the medial wall (near the orbital apex) could be clearly observed in the transnasal group, the anterior 1/3 of the medial wall was difficult to remove with the endoscope angle of 0 \u0026deg;, which could be corresponded anatomically to the agger nasi cell.\u003csup\u003e[\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e]\u003c/sup\u003e Besides, only 2 patients in the transnasal group and 6 in the transconjunctival group underwent the inferior wall decompression with the surgical accuracy of 57% and 88%, which was a too small sample size to reach a robust conclusion.\u003c/p\u003e \u003cp\u003eWe found that the preoperative and postoperative BCVA did not significantly differ in the two groups. This might be related to the fact that moderate-to-severe TAO patients without vision loss had the highest proportion in our study (Table\u0026nbsp;1). No significant difference was found in the ocular motility grade between the two groups. However, patients in the transconjunctival group had a worse diplopia grade after surgery. In Dubin et al.\u0026rsquo;s study, endoscopic orbital decompression with navigation caused the new-onset diplopia of 66.7%.\u003csup\u003e[\u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e]\u003c/sup\u003e In studies that employed transnasal decompression without navigation, the new-onset diplopia rate could reach 50\u0026ndash;100%\u003csup\u003e[\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e, \u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e]\u003c/sup\u003e. There are several factors that may influence new-onset diplopia, such as decompression range, the enlargement of extraocular muscles, and orbital compliance. \u003csup\u003e[\u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e, \u003cspan citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e]\u003c/sup\u003e In our study, we assumed that the transconjunctival approach might remove the medial wall to a greater extent that allowed the enlarged medial rectus muscle and retrobulbar fat to form hernia in ethmoid sinus. It was resulted in the displacement of medial rectus muscle, increasing the risk of esotropia and diplopia.\u003c/p\u003e \u003cp\u003eTherefore, we concentrated on the anterior 1/3 of the medial wall. This region might be important to prevent the displacement of eyeball, avoiding the appearance or deterioration of diplopia, which was mentioned in Wu et al.\u0026rsquo;s research. \u003csup\u003e[\u003cspan citationid=\"CR35\" class=\"CitationRef\"\u003e35\u003c/span\u003e]\u003c/sup\u003e The anterior 1/3 of the medial wall could be considered to preserve for patients with obvious hypertrophic medial rectus muscle or preoperative esotropia. We hypothesized that keeping the anterior 1/3 of the medial wall might be an appropriate choice for the orbital decompression.\u003c/p\u003e \u003cp\u003eFinally, the safety of orbital decompression via both approaches was confirmed. Only one patient in the transnasal group experienced postoperative infection and was treated after surgery.\u003c/p\u003e \u003cp\u003eThere were some limitations in our study. First, this was a single-center study with a small simple size. The randomization was not perfect in age. Second, a 12-month follow-up after surgery might result in more reliable and stable results. No subjective index included in the study was a pity. In addition, layered analysis would be carried out in the future study, which would lead to a more precise conclusion for the improvement of BCVA and the surgical accuracy of the inferior wall.\u003c/p\u003e"},{"header":"Conclusions","content":"\u003cp\u003eIn summary, endoscopic orbital decompression can effectively reduce proptosis with a promising safety. Both transconjuntival and transnasal approaches can be utilized by surgeons.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cp\u003eTAO \u0026nbsp; \u0026nbsp;Thyroid-associated ophthalmopathy\u003c/p\u003e\n\u003cp\u003eCT \u0026nbsp; \u0026nbsp; \u0026nbsp;Computed tomography\u003c/p\u003e\n\u003cp\u003eBCVA \u0026nbsp; Best-corrected visual acuity\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eRCT \u0026nbsp; \u0026nbsp;Randomized controlled trial\u003c/p\u003e\n\u003cp\u003eENS \u0026nbsp; \u0026nbsp;Endoscope-navigation system\u003c/p\u003e\n\u003cp\u003eCSF \u0026nbsp; \u0026nbsp;Cerebrospinal fluid\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003eAcknowledgements: Not Applicable\u003c/p\u003e\n\u003cp\u003eAuthors\u0026rsquo; contributions: Conceptualization, R.S., YW.L. and HF.Z.; methodology, R.S., YW.L. and HF.Z.; validation, R.S., HF.Z.; investigation, R.S., J.S., HF.Z. and YW.L.; resources, HF.Z.; data analysis, R.S. and J.S., HF.Z., YW.L.; writing\u0026mdash;original draft, R.S.; writing\u0026mdash;review and editing, J.S., YW.L., HF.Z., XF.S, S.Z.; visualization, R.S. and J.S.; supervision, R.S., HF.Z., and YW.L.; funding acquisition, HF.Z.. All authors have read and agreed to the published version of the manuscript.\u003c/p\u003e\n\u003cp\u003eFunding: Clinical research booster program of the Ninth People\u0026apos;s Hospital Affiliated to Shanghai Jiaotong University School of Medicine (JYLJ036); Shanghai Key Clinical Specialty; Shanghai Eye Disease Research Center (2022ZZ01003)\u003c/p\u003e\n\u003cp\u003eCompeting interests: None declared.\u003c/p\u003e\n\u003cp\u003eAvailability of data and materials: The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.\u003c/p\u003e\n\u003cp\u003eEthics approval and consent to participate: Ethical approval was obtained for this study by the local ethics committee.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eSmith TJ, Hegedus L. Graves' Disease. 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Endoscopic endonasal trans-sphenoidal optic nerve decompression for traumatic optic neuropathy\u0026ndash;technical note. Neurologia medico-chirurgica. 2010;50:518\u0026ndash;22.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGulati S, Ueland HO, Haugen OH, Danielsen A, R\u0026oslash;dahl E. Long-term follow-up of patients with thyroid eye disease treated with endoscopic orbital decompression. Acta Ophthalmol. 2015;93:178\u0026ndash;83.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMueller SK, Miyake MM, Lefebvre DR, Freitag SK, Bleier BS. Long-term impact of endoscopic orbital decompression on sinonasal-specific quality of life. Laryngoscope. 2018;128:785\u0026ndash;8.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSihota R, Angmo D, Ramaswamy D, Dada T. Simplifying target intraocular pressure for different stages of primary open-angle glaucoma and primary angle-closure glaucoma. Indian J Ophthalmol. 2018;66:495\u0026ndash;505.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eJi Y, Lai C, Gu L, Fan X. Measurement of Intra-Orbital Structures in Normal Chinese Adults Based on a Three-Dimensional Coordinate System. Curr Eye Res. 2018;43:1477\u0026ndash;83.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLi Y, Su Y, Song X, Zhou H, Fan X. What is the Main Potential Factor Influencing Ocular Protrusion? Med Sci Monit. 2017;23:57\u0026ndash;64.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSowerby LJ, Rajakumar C, Allen L, Rotenberg BW. Urgent endoscopic orbital decompression for vision deterioration in dysthyroid optic neuropathy. Eur Ann Otorhinolaryngol Head Neck Dis. 2019;136:S49\u0026ndash;52.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eCansiz H, Yilmaz S, Karaman E, Oğreden S, Acioğlu E, Sekercioğlu N, et al. Three wall orbital decompression superiority to 2-wall orbital decompression in thyroid-associated ophthalmopathy. J Oral Maxillofac Surg. 2006;64:763\u0026ndash;9.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eChu EA, Miller NR, Grant MP, Merbs S, Tufano RP, Lane AP. Surgical treatment of dysthyroid orbitopathy. Otolaryngol Head Neck Surg. 2009;141:39\u0026ndash;45.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eZhang S, Li YW, Song XF, Sun J, Zhou HF, Fan XQ. Effect of deep lateral wall orbital decompression in the treatment of thyroid-associated ophthalmopathy. Bengbu Med Coll. 2018;43:1359\u0026ndash;63.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eJuniat V, Abbeel L, McGilligan JA, Curragh D, Selva D, Rajak S. Endoscopic Orbital Decompression by Oculoplastic Surgeons for Proptosis in Thyroid Eye Disease. Ophthalmic Plast Reconstr Surg. 2019;35:590\u0026ndash;3.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMetson R, Samaha M. Reduction of Diplopia Following Endoscopic Orbital Decompression.The Orbital Sling Technique. Laryngoscope. 2002;112(10):1753\u0026ndash;7.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eDubin MR, Tabaee A, Scruggs JT, Kazim M, Close LG. Image-guided endoscopic orbital decompression for Graves' orbitopathy. Ann Otol Rhinol Laryngol. 2008;117:177\u0026ndash;85.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eCheng SN, Yu YQ, You YY, Chen J, Pi XH, Wang XH, et al. Comparison of 2-wall versus 3-wall orbital decompression against dysthyroid optic neuropathy in visual function: A retrospective study in a Chinese population. Med (Baltim). 2021;100:e24513.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGioacchini FM, Kaleci S, Cassandro E, Scarpa A, Tulli M, Cassandro C, et al. Orbital wall decompression in the management of Graves' orbitopathy: a systematic review with meta-analysis. Eur Arch Otorhinolaryngol. 2021;278:4135\u0026ndash;45.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eWu WC, Yu B, Wang ML, Huang L, Tu YH, Chen B, et al. Endoscopic trans-ethmoid medial orbital wall decompression combined with intraconal fat decompression for Graves' ophthalmopathy. Zhonghua Er Bi Yan Hou Tou Jing Wai Ke Za Zhi. 2011;46:807\u0026ndash;13.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"},{"header":"Tables","content":"\u003cp\u003e\u003cstrong\u003eTable.1\u003c/strong\u003e Baseline characteristics of study participants\u003c/p\u003e\n\u003ctable border=\"0\" cellspacing=\"0\" cellpadding=\"0\" align=\"\" width=\"614\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.178861788617887%\"\u003e\n \u003cp\u003eIndex\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003eTotal\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.463414634146343%\"\u003e\n \u003cp\u003eTransconjunctival group\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003eTransnasal group\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.357723577235772%\"\u003e\n \u003cp\u003eP\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.178861788617887%\"\u003e\n \u003cp\u003eMale\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e23\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.463414634146343%\"\u003e\n \u003cp\u003e10\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e13\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.357723577235772%\" rowspan=\"2\"\u003e\n \u003cp\u003e0.386\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"29.87012987012987%\"\u003e\n \u003cp\u003eFemale\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.820037105751393%\"\u003e\n \u003cp\u003e25\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"24.489795918367346%\"\u003e\n \u003cp\u003e14\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.820037105751393%\"\u003e\n \u003cp\u003e11\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.178861788617887%\"\u003e\n \u003cp\u003eAge\u003c/p\u003e\n \u003cp\u003ey, Mean\u0026plusmn;SD\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e38.02\u0026plusmn;11.81\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.463414634146343%\"\u003e\n \u003cp\u003e42.67 \u0026plusmn;14.52\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e33.38\u0026plusmn;5.42\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.357723577235772%\"\u003e\n \u003cp\u003e0.005\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.178861788617887%\"\u003e\n \u003cp\u003eModerate-to-severe\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e42\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.463414634146343%\"\u003e\n \u003cp\u003e19\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e23\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.357723577235772%\" rowspan=\"2\"\u003e\n \u003cp\u003e0.081 \u0026nbsp;\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"29.87012987012987%\"\u003e\n \u003cp\u003eSight-threatening\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.820037105751393%\"\u003e\n \u003cp\u003e6\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"24.489795918367346%\"\u003e\n \u003cp\u003e5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.820037105751393%\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.178861788617887%\"\u003e\n \u003cp\u003eCAS\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e1.00 [0.00, 2.00]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.463414634146343%\"\u003e\n \u003cp\u003e1.00 [1.00, 2.00]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e1.00 [0.00, 1.00]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.357723577235772%\"\u003e\n \u003cp\u003e0.122\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.178861788617887%\"\u003e\n \u003cp\u003eRight\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e22\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.463414634146343%\"\u003e\n \u003cp\u003e12\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e10\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.357723577235772%\" rowspan=\"2\"\u003e\n \u003cp\u003e0.562\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"29.87012987012987%\"\u003e\n \u003cp\u003eLeft\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.820037105751393%\"\u003e\n \u003cp\u003e26\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"24.489795918367346%\"\u003e\n \u003cp\u003e12\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.820037105751393%\"\u003e\n \u003cp\u003e14\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.178861788617887%\"\u003e\n \u003cp\u003eSmoking history\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e13\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.463414634146343%\"\u003e\n \u003cp\u003e5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e7\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.357723577235772%\" rowspan=\"2\"\u003e\n \u003cp\u003e0.505\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"29.87012987012987%\"\u003e\n \u003cp\u003eNo Smoking history\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.820037105751393%\"\u003e\n \u003cp\u003e35\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"24.489795918367346%\"\u003e\n \u003cp\u003e19\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.820037105751393%\"\u003e\n \u003cp\u003e17\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.178861788617887%\"\u003e\n \u003cp\u003eProptosis\u003c/p\u003e\n \u003cp\u003emm，Mean\u0026plusmn;SD\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e21.20\u0026plusmn;2.16\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.463414634146343%\"\u003e\n \u003cp\u003e21.42\u0026plusmn;2.40\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e20.97\u0026plusmn;1.91\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.357723577235772%\"\u003e\n \u003cp\u003e0.478\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.178861788617887%\"\u003e\n \u003cp\u003eVisual acuity\u003c/p\u003e\n \u003cp\u003elogMAR, M [P25,P75]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e0.14\u0026plusmn;0.27\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.463414634146343%\"\u003e\n \u003cp\u003e0.19\u0026plusmn;0.32\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e0.09\u0026plusmn;0.21\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.357723577235772%\"\u003e\n \u003cp\u003e0.214\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.178861788617887%\"\u003e\n \u003cp\u003eOcular motility grade\u003c/p\u003e\n \u003cp\u003eM [P25,P75]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e1.10\u0026plusmn;0.75\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.463414634146343%\"\u003e\n \u003cp\u003e1.29\u0026plusmn;0.75\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e0.92\u0026plusmn;0.72\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.357723577235772%\"\u003e\n \u003cp\u003e0.083\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.178861788617887%\"\u003e\n \u003cp\u003eDiplopia grade\u003c/p\u003e\n \u003cp\u003eM [P25,P75]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e0.82\u0026plusmn;1.05\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.463414634146343%\"\u003e\n \u003cp\u003e1.00\u0026plusmn;1.03\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20%\"\u003e\n \u003cp\u003e0.63\u0026plusmn;1.07\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.357723577235772%\"\u003e\n \u003cp\u003e0.278\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eMean\u0026plusmn;SD = mean\u0026plusmn;standard deviation\u003c/p\u003e\n\u003cp\u003eM [P25,P75] = median [interquartile interval].\u003c/p\u003e\n\u003cp\u003elogMAR = logarithm to the minimal angle of resolution\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTable.2\u0026nbsp;\u003c/strong\u003eComparison table of transconjunctival and transnasal group\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"644\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd width=\"24.96124031007752%\"\u003e\n \u003cp\u003eIndex\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.015503875968992%\"\u003e\n \u003cp\u003eTotal\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.015503875968992%\"\u003e\n \u003cp\u003eTransconjunctival\u003c/p\u003e\n \u003cp\u003egroup\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.015503875968992%\"\u003e\n \u003cp\u003eTransnasal\u003c/p\u003e\n \u003cp\u003egroup\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"8.992248062015504%\"\u003e\n \u003cp\u003eP\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"24.96124031007752%\"\u003e\n \u003cp\u003eProptosis reduction\u003c/p\u003e\n \u003cp\u003emm，Mean\u0026plusmn;SD\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.015503875968992%\"\u003e\n \u003cp\u003e4.89\u0026plusmn;2.21\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.015503875968992%\"\u003e\n \u003cp\u003e5.38\u0026plusmn;2.60\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.015503875968992%\"\u003e\n \u003cp\u003e4.40\u0026plusmn;1.66\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"8.992248062015504%\"\u003e\n \u003cp\u003e0.435\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"24.96124031007752%\"\u003e\n \u003cp\u003eVision improved, n\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.015503875968992%\"\u003e\n \u003cp\u003e14\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.015503875968992%\"\u003e\n \u003cp\u003e8\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.015503875968992%\"\u003e\n \u003cp\u003e6\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"8.992248062015504%\"\u003e\n \u003cp\u003e0.671\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"24.96124031007752%\"\u003e\n \u003cp\u003eOcular motility grade\u003c/p\u003e\n \u003cp\u003edecreased, n\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.015503875968992%\"\u003e\n \u003cp\u003e8\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.015503875968992%\"\u003e\n \u003cp\u003e5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.015503875968992%\"\u003e\n \u003cp\u003e3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"8.992248062015504%\"\u003e\n \u003cp\u003e0.108\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"24.96124031007752%\"\u003e\n \u003cp\u003eOcular motility grade\u003c/p\u003e\n \u003cp\u003eincreased, n\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.015503875968992%\"\u003e\n \u003cp\u003e11\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.015503875968992%\"\u003e\n \u003cp\u003e3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.015503875968992%\"\u003e\n \u003cp\u003e8\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"8.992248062015504%\"\u003e\n \u003cp\u003e0.342\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"24.96124031007752%\"\u003e\n \u003cp\u003eDiplopia grade\u003c/p\u003e\n \u003cp\u003edecreased, n\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.015503875968992%\"\u003e\n \u003cp\u003e5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.015503875968992%\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.015503875968992%\"\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"8.992248062015504%\"\u003e\n \u003cp\u003e0.082\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"24.96124031007752%\"\u003e\n \u003cp\u003eDiplopia grade\u003c/p\u003e\n \u003cp\u003eincreased, n\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.015503875968992%\"\u003e\n \u003cp\u003e12\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.015503875968992%\"\u003e\n \u003cp\u003e6\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.015503875968992%\"\u003e\n \u003cp\u003e6\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"8.992248062015504%\"\u003e\n \u003cp\u003e0.706\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"24.96124031007752%\"\u003e\n \u003cp\u003eNew-onset diplopia, n\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.015503875968992%\"\u003e\n \u003cp\u003e9\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.015503875968992%\"\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.015503875968992%\"\u003e\n \u003cp\u003e5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"8.992248062015504%\"\u003e\n \u003cp\u003e0.888\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"24.96124031007752%\"\u003e\n \u003cp\u003eMedial wall accuracy\u003c/p\u003e\n \u003cp\u003eM [P25,P75]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.015503875968992%\"\u003e\n \u003cp\u003e0.92 [0.87, 0.94]，\u003c/p\u003e\n \u003cp\u003en=46\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.015503875968992%\"\u003e\n \u003cp\u003e0.94 [0.92, 0.97]，\u003c/p\u003e\n \u003cp\u003en=22\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.015503875968992%\"\u003e\n \u003cp\u003e0.89 [0.82, 0.92]，\u003c/p\u003e\n \u003cp\u003en=24\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"8.992248062015504%\"\u003e\n \u003cp\u003e0.001\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"24.96124031007752%\"\u003e\n \u003cp\u003eInferior wall accuracy\u003c/p\u003e\n \u003cp\u003eM [P25,P75]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.015503875968992%\"\u003e\n \u003cp\u003e0.79[0.63, 0.91]，\u003c/p\u003e\n \u003cp\u003en=8\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.015503875968992%\"\u003e\n \u003cp\u003e0.88 [0.75, 0.91]，\u003c/p\u003e\n \u003cp\u003en=6\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.015503875968992%\"\u003e\n \u003cp\u003e0.57 [0.53, 0.62]，\u003c/p\u003e\n \u003cp\u003en=2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"8.992248062015504%\"\u003e\n \u003cp\u003e0.149\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"24.96124031007752%\"\u003e\n \u003cp\u003eLateral wall accuracy\u003c/p\u003e\n \u003cp\u003eM [P25,P75]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.015503875968992%\"\u003e\n \u003cp\u003e0.90 [0.83, 0.91]，\u003c/p\u003e\n \u003cp\u003en=37\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.015503875968992%\"\u003e\n \u003cp\u003e0.91 [0.88, 0.91]，\u003c/p\u003e\n \u003cp\u003en=16\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.015503875968992%\"\u003e\n \u003cp\u003e0.88 [0.83, 0.92]，\u003c/p\u003e\n \u003cp\u003en=21\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"8.992248062015504%\"\u003e\n \u003cp\u003e0.631\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eMean\u0026plusmn;SD = mean\u0026plusmn;standard deviation\u003c/p\u003e\n\u003cp\u003eM [P25,P75] = median [interquartile interval].\u003c/p\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":"thyroid-associated ophthalmopathy, endoscope, surgical approach","lastPublishedDoi":"10.21203/rs.3.rs-4008440/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-4008440/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\u003eTo compare the effectiveness of endoscopic orbital decompression by two surgical approaches for thyroid-associated ophthalmopathy (TAO).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eA prospective, randomized controlled trial was performed on 48 moderate-to-severe or sight-threatening TAO orbits. All patients, who were randomly assigned into transconjunctival group or transnasal group, underwent endoscopic orbital decompression according to the surgical design. Clinical and radiological data were collected at baseline and 3 months after surgery by a masked investigator. The main outcome was the effective rate. If the postoperative proptosis measured by computed tomography (CT) was below 18 mm or the value of proptosis reduction was over 8 mm, it would be defined as effective. The secondary outcomes included surgical accuracy, best-corrected visual acuity (BCVA), ocular motility grade, diplopia grade, and safety.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e48 orbits of 41 patients were enrolled in the study, with 24 orbits each in transconjunctival and transnasal group. The effective rate was 87.5% in the transconjunctival group and it was 79.2% in the transnasal group (P = 0.087). The proptosis reduction was 5.38 ± 2.60 mm in the transconjunctival group and 4.40 ± 1.66 mm in the transnasal group (P = 0.435). A significant difference was found between preoperative and postoperative proptosis in both groups (P \u0026lt; 0.01). In the transconjunctival group, a higher surgical accuracy in the medial wall was found (P = 0.001). There was no significant difference in both groups between preoperative and postoperative BCVA and ocular motility grade. Complications showed no significant difference between two groups (P \u0026gt; 0.05).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusion\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eBoth transconjuntival and transnasal endoscopic orbital decompression were feasible, and could be utilized by surgeons.\u003c/p\u003e\n\u003cp\u003eThis study was registered with Chinese clinical trial registry (Trial registration number: ChiCTR-INR-17013268; date of access and registration: November 3, 2017).\u003c/p\u003e","manuscriptTitle":"Comparison of Transconjunctival and Transnasal approaches for orbital decompression: A randomized controlled trial","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-03-11 19:16:29","doi":"10.21203/rs.3.rs-4008440/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":"3ef10835-13f1-42d9-a525-fa06369f1e6a","owner":[],"postedDate":"March 11th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2024-03-15T14:37:05+00:00","versionOfRecord":[],"versionCreatedAt":"2024-03-11 19:16:29","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-4008440","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-4008440","identity":"rs-4008440","version":["v1"]},"buildId":"qtupq5eGEP_6zYnWcrvyt","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}