RecruitingNot ApplicableNCT07095907

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

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

Sponsor

Asociación para Evitar la Ceguera en México

Enrollment

36 participants

Start Date

Jun 10, 2025

Study Type

INTERVENTIONAL

Conditions

Epiretinal Membrane Surgery

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

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 Criteria2

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.

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Interventions

PROCEDUREPars 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.

Locations(1)

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

Mexico City, Mexico

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NCT07095907