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This study aims to evaluate postsurgical functional changes in patients with advanced epiretinal membrane (ERM) (stages 3 and 4) by integrating a controlled macular detachment with a balanced salt solution to the conventional ERM peeling technique.
The evolution of visual acuity will be analyzed using the ETDRS letter scale. At the same time, anatomical and microvascular changes will be evaluated using optical coherence tomography (OCT) and optical coherence tomography angiography (OCT-A) to evaluate their impact on visual recovery. This technique is expected to minimize persistent distortion, promote restoration of retinal perfusion, mitigate postoperative ischemia, and improve macular structural stability, potentially leading to more significant functional recovery. It is designed as a prospective longitudinal pilot study; The research will be carried out in the Retina Department of the Association to Prevent Blindness in Mexico (APEC), focusing on patients over 18 years of age with a diagnosis of advanced MRD and eligible for vitreoretinal surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient protocol | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pars plana vitrectomy with epiretinal membrane peeling and controlled macular detachment | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| BCVA (Best corrected visual acuity) | Ability to discriminate fine details at a standard distance, assessed by reading letters on an ETDRS chart. | From the first recruitment evaluation to the last one at 3 months post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative anatomical changes of the macula using optical coherence tomography: Central macular thickness (µm) | Central macular thickness measured in microns (µm) | From enrollment to the end of follow-up at the third month. |
| Postoperative anatomical changes of the macula using optical coherence tomography: Inner nuclear layer thickness (µm) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Raúl Velez Montoya, MD | Contact | (52) 55 5436 7335 | rvelezmx@yahoo.com | |
| Oriana Gomez Erazo, MD | Contact | 57 3205605466 | orianagomezerazo@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Raul Velez, MD | Asociación para Evitar la Ceguera en México | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Asociación Para Evitar la Ceguera en México I.A.P. | Recruiting | Mexico City | 04030 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36880022 | Background | 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. | |
| 28622372 | Background | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 20, 2025 | Jul 17, 2025 |
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Prospective, Longitudinal, Experimental, Descriptive Cohort Study.
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|
Inner nuclear layer thickness measured in microns (µm) |
| From enrollment to the end of follow-up at the third month. |
| Postoperative anatomical changes of the macula using optical coherence tomography: Ellipsoid zone disruption | Presence or absence of disruption of the Ellipsoid layer | From enrollment to the end of follow-up at the third month. |
| 35169203 | Background | 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. |
| 31757497 | Background | 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. |
| 26220819 | Background | 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. |
| 17065517 | Background | 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. |
| 32764657 | Background | 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. |
| 38117309 | Background | 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. |
| 33815835 | Background | 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. |
| 38396450 | Background | 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. |
| 28816729 | Background | 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. |
| 39661356 | Background | 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. |
| 38097656 | Background | 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. |
| 29160787 | Background | 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. |
| 27993592 | Background | 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. |
| 3740180 | Background | 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. |
| 24324293 | Background | 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. |
| 8594634 | Background | 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. |
| 36249297 | Background | 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. |
| 33307784 | Background | 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. |
| 23400080 | Background | 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. |
| 33656784 | Background | 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. |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D019773 | Epiretinal Membrane |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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