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NCT Number: NCT07095907

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Asociación Para Evitar la Ceguera en México I.A.P.

Mexico City, 04030, Mexico

Location status: Recruiting

Location contact

Oriana Gomez, MD

CONTACT

[email protected]

52 5510841400 ext. 1302

Raul Velez, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pars plana vitrectomy with epiretinal membrane peeling and controlled macular detachment

Procedure

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.

Primary outcomes

  1. BCVA (Best corrected visual acuity)

    Time frame: 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 outcomes

  1. Postoperative anatomical changes of the macula using optical coherence tomography: Central macular thickness (µm)

    Time frame: From enrollment to the end of follow-up at the third month.

    Central macular thickness measured in microns (µm)

  2. Postoperative anatomical changes of the macula using optical coherence tomography: Inner nuclear layer thickness (µm)

    Time frame: From enrollment to the end of follow-up at the third month.

    Inner nuclear layer thickness measured in microns (µm)

  3. Postoperative anatomical changes of the macula using optical coherence tomography: Ellipsoid zone disruption

    Time frame: From enrollment to the end of follow-up at the third month.

    Presence or absence of disruption of the Ellipsoid layer

Study contacts

Contact information is provided by the study sponsor or research team.

Oriana Gomez Erazo, MD

CONTACT

[email protected]

57 3205605466

Raúl Velez Montoya, MD

CONTACT

[email protected]

(52) 55 5436 7335

Sponsors and collaborators

Lead sponsor

Asociación para Evitar la Ceguera en México

Other

Registry information

Official study title

Post-surgical Functional Results in Patients With Epiretinal Membrane Undergoing Controlled Macular Detachment: Pilot Study.

Acronym: DMER25

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jul 31, 2025
Registry last updated
Jul 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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