Post-surgical Functional Results in Patients With Epiretinal Membrane Undergoing Controlled Macular Detachment
NCT ID: NCT07095907
Last Updated: 2025-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
36 participants
INTERVENTIONAL
2025-06-10
2026-01-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Patient protocol
Patients over 18 years of age, with a clinical diagnosis of Epiretinal Membrane grade 3 and 4 according to Optical Coherence Tomography, who attend the Retina service.
Pars plana vitrectomy with epiretinal membrane peeling and controlled macular detachment
Currently, vitrectomy with epiretinal membrane peeling is the standard procedure; however, its ability to improve visual acuity in these patients remains limited. In this context, controlled macular detachment is emerging as a surgical alternative that could optimize the anatomical and functional restoration of the retina.
Interventions
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Pars plana vitrectomy with epiretinal membrane peeling and controlled macular detachment
Currently, vitrectomy with epiretinal membrane peeling is the standard procedure; however, its ability to improve visual acuity in these patients remains limited. In this context, controlled macular detachment is emerging as a surgical alternative that could optimize the anatomical and functional restoration of the retina.
Eligibility Criteria
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Inclusion Criteria
* Patients with a confirmed diagnosis of ERM grade III or IV by Optical Coherence Tomography who present visual disturbances such as metamorphopsia or visual impairment (measured in letters on the ETDRS scale) but who do not reflect end-stage visual impairment.
* Patients suitable for vitreoretinal surgical procedures, with no uncontrolled medical comorbidities that contraindicate surgery.
* Patients who understand the objectives and risks of the study and sign an informed consent form.
Exclusion Criteria
* Patients diagnosed with ocular pathologies that significantly affect their visual acuity, such as moderate or advanced glaucoma, non-glaucomatous optic neuropathies, or optic media opacities such as leukomas, significant corneal edema, or other maculopathies such as macular atrophy or macular ischemia.
18 Years
ALL
No
Sponsors
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Asociación para Evitar la Ceguera en México
OTHER
Responsible Party
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Principal Investigators
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Raul Velez, MD
Role: PRINCIPAL_INVESTIGATOR
Asociación para Evitar la Ceguera en México
Locations
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Hospital Asociación Para Evitar la Ceguera en México I.A.P.
Mexico City, , Mexico
Countries
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Central Contacts
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Facility Contacts
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References
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Abu-Ain M, Shatnawi R, Shehadeh I, Khan MI. Long-Term Visual Acuity and Optical Coherence Tomography Changes After Vitrectomy for Idiopathic Epiretinal Membranes. Clin Ophthalmol. 2023 Feb 28;17:693-700. doi: 10.2147/OPTH.S401017. eCollection 2023.
Chang WC, Lin C, Lee CH, Sung TL, Tung TH, Liu JH. Vitrectomy with or without internal limiting membrane peeling for idiopathic epiretinal membrane: A meta-analysis. PLoS One. 2017 Jun 16;12(6):e0179105. doi: 10.1371/journal.pone.0179105. eCollection 2017.
Khanna RK, Dorvault M, Pasco J, Cook AR, Pichard T, Marotte MT, Pisella PJ, Arsene S. Long-term functional outcomes and vision-related quality of life after vitrectomy for epiretinal membrane: a prospective cohort study. Sci Rep. 2022 Feb 15;12(1):2470. doi: 10.1038/s41598-022-06482-3.
Flaxel CJ, Adelman RA, Bailey ST, Fawzi A, Lim JI, Vemulakonda GA, Ying GS. Idiopathic Epiretinal Membrane and Vitreomacular Traction Preferred Practice Pattern(R). Ophthalmology. 2020 Feb;127(2):P145-P183. doi: 10.1016/j.ophtha.2019.09.022. Epub 2019 Sep 25. No abstract available.
Morizane Y, Kimura S, Hosokawa M, Shiode Y, Hirano M, Doi S, Hosogi M, Fujiwara A, Inoue Y, Shiraga F. Planned foveal detachment technique for the resolution of diffuse diabetic macular edema. Jpn J Ophthalmol. 2015 Sep;59(5):279-87. doi: 10.1007/s10384-015-0390-4. Epub 2015 Jul 30.
Szurman P, Roters S, Grisanti S, Aisenbrey S, Schraermeyer U, Luke M, Bartz-Schmidt KU, Thumann G. Ultrastructural changes after artificial retinal detachment with modified retinal adhesion. Invest Ophthalmol Vis Sci. 2006 Nov;47(11):4983-9. doi: 10.1167/iovs.06-0491.
Momota A, Iwase T, Akahori T, Goto K, Yamamoto K, Ra E, Terasaki H. Association between displacement and thickness of macula after vitrectomy in eyes with epiretinal membrane. Sci Rep. 2020 Aug 6;10(1):13227. doi: 10.1038/s41598-020-70197-6.
Choi KE, Kim S, Kim SW. Anatomical changes in idiopathic epiretinal membrane at 2-year follow-up assessed using spectral domain optical coherence tomography and optical coherence tomographic angiography. Graefes Arch Clin Exp Ophthalmol. 2024 May;262(5):1465-1474. doi: 10.1007/s00417-023-06332-6. Epub 2023 Dec 20.
Bacherini D, Dragotto F, Caporossi T, Lenzetti C, Finocchio L, Savastano A, Savastano MC, Barca F, Dragotto M, Vannozzi L, Nasini F, Faraldi F, Rizzo S, Virgili G, Giansanti F. The Role of OCT Angiography in the Assessment of Epiretinal Macular Membrane. J Ophthalmol. 2021 Mar 24;2021:8866407. doi: 10.1155/2021/8866407. eCollection 2021.
Baldascino A, Carla MM, Vielmo L, Gambini G, Marzano FC, Margollicci F, D'Onofrio NC, Rizzo S. Microvascular Changes after Epiretinal Membrane Vitrectomy with Intraoperative Intravitreal Dexamethasone Implant: An OCT Angiography Analysis. Diagnostics (Basel). 2024 Feb 13;14(4):411. doi: 10.3390/diagnostics14040411.
Wong R, Howard C, Orobona GD. RETINA EXPANSION TECHNIQUE FOR MACULAR HOLE APPOSITION REPORT 2: Efficacy, Closure Rate, and Risks of a Macular Detachment Technique to Close Large Full-Thickness Macular Holes. Retina. 2018 Apr;38(4):660-663. doi: 10.1097/IAE.0000000000001705.
Yang HS, Choi S, Kim S, Min CH, Kim D, Lee Y, Kim M, Koo D, Ryu J, Kim J. Epiretinal Membrane: Correlations Among Clinical, Immunohistochemical, and Biochemical Features and Their Prognostic Implications. Invest Ophthalmol Vis Sci. 2024 Dec 2;65(14):25. doi: 10.1167/iovs.65.14.25.
Miyazato M, Iwashita Y, Hirono K, Ching J, Nakamura K, Inoue T, Asaoka R, Yanagi Y, Maruyama-Inoue M, Kadonosono K. Predictive factors for postoperative visual function in eyes with epiretinal membrane. Sci Rep. 2023 Dec 14;13(1):22198. doi: 10.1038/s41598-023-49689-8.
Govetto A, Virgili G, Rodriguez FJ, Figueroa MS, Sarraf D, Hubschman JP. FUNCTIONAL AND ANATOMICAL SIGNIFICANCE OF THE ECTOPIC INNER FOVEAL LAYERS IN EYES WITH IDIOPATHIC EPIRETINAL MEMBRANES: Surgical Results at 12 Months. Retina. 2019 Feb;39(2):347-357. doi: 10.1097/IAE.0000000000001940.
Govetto A, Lalane RA 3rd, Sarraf D, Figueroa MS, Hubschman JP. Insights Into Epiretinal Membranes: Presence of Ectopic Inner Foveal Layers and a New Optical Coherence Tomography Staging Scheme. Am J Ophthalmol. 2017 Mar;175:99-113. doi: 10.1016/j.ajo.2016.12.006. Epub 2016 Dec 18.
Wiznia RA. Posterior vitreous detachment and idiopathic preretinal macular gliosis. Am J Ophthalmol. 1986 Aug 15;102(2):196-8. doi: 10.1016/0002-9394(86)90144-3.
Joshi M, Agrawal S, Christoforidis JB. Inflammatory mechanisms of idiopathic epiretinal membrane formation. Mediators Inflamm. 2013;2013:192582. doi: 10.1155/2013/192582. Epub 2013 Nov 11.
Hikichi T, Takahashi M, Trempe CL, Schepens CL. Relationship between premacular cortical vitreous defects and idiopathic premacular fibrosis. Retina. 1995;15(5):413-6. doi: 10.1097/00006982-199515050-00007.
Liew G, Nguyen H, Ho IV, White AJ, Burlutsky G, Gopinath B, Mitchell P. Prevalence of Vitreoretinal Interface Disorders in an Australian Population: The Blue Mountains Eye Study. Ophthalmol Sci. 2021 Apr 19;1(2):100019. doi: 10.1016/j.xops.2021.100019. eCollection 2021 Jun.
Karasavvidou EM, Panos GD, Koronis S, Kozobolis VP, Tranos PG. Optical coherence tomography biomarkers for visual acuity in patients with idiopathic epiretinal membrane. Eur J Ophthalmol. 2021 Nov;31(6):3203-3213. doi: 10.1177/1120672120980951. Epub 2020 Dec 14.
Aung KZ, Makeyeva G, Adams MK, Chong EW, Busija L, Giles GG, English DR, Hopper J, Baird PN, Guymer RH, Robman LD. The prevalence and risk factors of epiretinal membranes: the Melbourne Collaborative Cohort Study. Retina. 2013 May;33(5):1026-34. doi: 10.1097/IAE.0b013e3182733f25.
Fung AT, Galvin J, Tran T. Epiretinal membrane: A review. Clin Exp Ophthalmol. 2021 Apr;49(3):289-308. doi: 10.1111/ceo.13914. Epub 2021 Mar 24.
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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RE-25-09
Identifier Type: -
Identifier Source: org_study_id
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