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Recruiting NCT07095907

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

No phase Interventional Epiretinal Membrane Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pars plana vitrectomy with epiretinal membrane peeling and controlled macular detachment.
Who it may be relevant to
Registry conditions: Epiretinal Membrane Surgery. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Mexico
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Post-surgical Functional Results in Patients With Epiretinal Membrane Undergoing Controlled Macular Detachment: Pilot Study.

Overview

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.

Detailed description

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.

Interventions

  • Procedure 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.

Primary outcome measures

  • BCVA (Best corrected visual acuity) [Time frame: From the first recruitment evaluation to the last one at 3 months post-surgery]
Secondary outcome measures (3)
  • Postoperative anatomical changes of the macula using optical coherence tomography: Central macular thickness (µm) [Time frame: 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) [Time frame: 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 [Time frame: From enrollment to the end of follow-up at the third month.]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Mexico · 1 center
  • Hospital Asociación Para Evitar la Ceguera en México I.A.P. — Mexico City

Publications

  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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

Identifiers

NCT: NCT07095907 · RE-25-09

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗