Vision recovery after epiretinal membrane removal with controlled macular detachment
Post-surgical Functional Results in Patients With Epiretinal Membrane Undergoing Controlled Macular Detachment: Pilot Study.
This test sees if adding a controlled macular detachment during epiretinal membrane surgery helps adults with advanced (stage 3–4) ERM recover vision.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Asociación para Evitar la Ceguera en México Academic / other |
| Locations | 1 site (Mexico City) |
| Trial ID | NCT07095907 on ClinicalTrials.gov |
What this trial studies
This is a prospective longitudinal pilot study at the Retina Department of the Asociación para Evitar la Ceguera en México enrolling adults with stage 3–4 epiretinal membrane who are candidates for vitrectomy. Participants undergo pars plana vitrectomy with epiretinal membrane peeling combined with a controlled macular detachment using balanced salt solution. Visual outcomes will be tracked with ETDRS letter scores and anatomical and microvascular changes assessed by OCT and OCT-A at scheduled postoperative visits. The technique is intended to reduce persistent distortion, restore retinal perfusion, and improve macular structural stability to support functional recovery.
Who should consider this trial
Good fit: Adults over 18 with confirmed stage III or IV epiretinal membrane who have symptoms such as metamorphopsia or decreased ETDRS letter acuity and are suitable for vitreoretinal surgery are ideal candidates.
Not a fit: Patients with end-stage visual loss or coexisting ocular diseases that prevent visual improvement (for example advanced glaucoma, optic neuropathies, significant corneal opacities, or other maculopathies) are unlikely to benefit.
Why it matters
Potential benefit: If successful, the approach could lead to better visual acuity and less persistent metamorphopsia after ERM surgery.
How similar studies have performed: This specific controlled macular detachment technique is relatively novel with limited published data, and only small case series or pilot reports have suggested possible benefit so far.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Mexico City
- Hospital Asociación Para Evitar la Ceguera en México I.A.P. — Mexico City, Mexico (Recruiting)
Study contacts
- Principal investigator: Raul Velez, MD — Asociación para Evitar la Ceguera en México
- Study coordinator: Raúl Velez Montoya, MD
- Email: rvelezmx@yahoo.com
- Phone: (52) 55 5436 7335
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.