NCT07095907

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.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Asociación para Evitar la Ceguera en México · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Epiretinal Membrane Surgery

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-06-10
• Primary completion: 2025-12-17
• Completion: 2026-01-26
• First posted: 2025-07-31
• Last updated: 2025-07-31

Locations

1 site across 1 country: Mexico