Health TrialsbyHealthPanel

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

ConditionEpiretinal Membrane Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAsociación para Evitar la Ceguera en México

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Design model

Single group

Treatments tested in this trial

  • Pars plana vitrectomy with epiretinal membrane peeling and controlled macular detachment

    Procedure/Surgery

    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.

Treatment groups

36 Participants
are divided into 1 treatment group
Group A: Patient protocolExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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.
2

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.
3

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Asociación para Evitar la Ceguera en México

Lead sponsor

Source ClinicalTrials.gov
Apply now