An interventional study of Pars plana vitrectomy with epiretinal membrane peeling and controlled macular detachment in Epiretinal Membrane Surgery, sponsored by Asociación para Evitar la Ceguera en México. Recruiting at 1 site in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-31.
Sponsored by Asociación para Evitar la Ceguera en México · Not applicable, Interventional, and Treatment
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.
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.
130 studies on the registry are indexed under Epiretinal Membrane; 18 are open to participants now.
This study's planned enrollment of 36 is below the median of 51 across 79 interventional studies indexed under Epiretinal Membrane.
Browse Epiretinal Membrane studies →Asociación para Evitar la Ceguera en México is the lead sponsor of 60 studies on the registry; 6 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
BCVA (Best corrected visual acuity)
Ability to discriminate fine details at a standard distance, assessed by reading letters on an ETDRS chart.
Time frame: From the first recruitment evaluation to the last one at 3 months post-surgery
Postoperative anatomical changes of the macula using optical coherence tomography: Central macular thickness (µm)
Central macular thickness measured in microns (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)
Inner nuclear layer thickness measured in microns (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
Presence or absence of disruption of the Ellipsoid layer
Time frame: From enrollment to the end of follow-up at the third month.
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Asociación para Evitar la Ceguera en México