Epiretinal Membrane Surgery
Conditions
Keywords
Epiretinal membrane, Epiretinal membrane surgery, Macular detachment
Brief 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.
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.
Sponsors
Asociación para Evitar la Ceguera en México
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, Longitudinal, Experimental, Descriptive Cohort Study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BCVA (Best corrected visual acuity) | From the first recruitment evaluation to the last one at 3 months post-surgery | Ability to discriminate fine details at a standard distance, assessed by reading letters on an ETDRS chart. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative anatomical changes of the macula using optical coherence tomography: Central macular thickness (µm) | From enrollment to the end of follow-up at the third month. | Central macular thickness measured in microns (µm) |
| Postoperative anatomical changes of the macula using optical coherence tomography: Inner nuclear layer thickness (µm) | From enrollment to the end of follow-up at the third month. | Inner nuclear layer thickness measured in microns (µm) |
| Postoperative anatomical changes of the macula using optical coherence tomography: Ellipsoid zone disruption | From enrollment to the end of follow-up at the third month. | Presence or absence of disruption of the Ellipsoid layer |
Countries
Mexico
Contacts
Primary ContactRaúl Velez Montoya, MD
Backup ContactOriana Gomez Erazo, MD
Outcome results
None listed