Post-surgical Functional Results in Patients With Epiretinal Membrane Undergoing Controlled Macular Detachment

NCT07095907 | Recruiting DMC

• 1 other identifier: RE-25-09
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Epiretinal Membrane Surgery

Keywords

Epiretinal membrane; Epiretinal membrane surgery; Macular detachment

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Postoperative anatomical changes of the macula using optical coherence tomography: Central macular thickness (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)

  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

  From enrollment to the end of follow-up at the third month.

Study Arms (1)

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.

Procedure: Pars plana vitrectomy with epiretinal membrane peeling and controlled macular detachment

Interventions

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.

Patient protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 18 years of age.
• 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.

You may not qualify if:

• Patients with a confirmed diagnosis of grade III or IV ERM by Optical Coherence Tomography who do not have the ability to improve their visual acuity.
• 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.

Sponsors & Collaborators

• Asociación para Evitar la Ceguera en México: lead

Study Sites (1)

Hospital Asociación Para Evitar la Ceguera en México I.A.P.

Mexico City, 04030, Mexico

RECRUITING

Related Publications (22)

• 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.

  PMID: 36880022 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.

  PMID: 28622372 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.

  PMID: 35169203 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.

  PMID: 31757497 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.

  PMID: 26220819 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.

  PMID: 17065517 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.

  PMID: 32764657 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.

  PMID: 38117309 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.

  PMID: 33815835 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.

  PMID: 38396450 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.

  PMID: 28816729 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.

  PMID: 39661356 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.

  PMID: 38097656 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.

  PMID: 29160787 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.

  PMID: 27993592 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.

  PMID: 3740180 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.

  PMID: 24324293 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.

  PMID: 8594634 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.

  PMID: 36249297 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.

  PMID: 33307784 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.

  PMID: 23400080 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.

  PMID: 33656784 BACKGROUND

MeSH Terms

Conditions

Epiretinal Membrane

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Study Officials

• Raul Velez, MD

  Asociación para Evitar la Ceguera en México

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raúl Velez Montoya, MD

CONTACT

(52) 55 5436 7335; rvelezmx@yahoo.com

Oriana Gomez Erazo, MD

CONTACT

57 3205605466; orianagomezerazo@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, Longitudinal, Experimental, Descriptive Cohort Study.

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: July 31, 2025
• Study Start: June 10, 2025
• Primary Completion: December 17, 2025
• Study Completion: January 26, 2026
• Last Updated: July 31, 2025

Record last verified: 2025-07

Locations

ME (1)