Post-surgical Functional Results in Patients With Epiretinal Membrane Undergoing Controlled Macular Detachment (DMER25)

Asociación para Evitar la Ceguera en México

Status: Enrolling

Conditions: Epiretinal Membrane Surgery

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07095907

RE-25-09

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

Patient protocol

Experimental group

Description:

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.

Treatment:

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