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NCT Number: NCT07142785

Clinical Evaluation of With or Without Internal Limiting Membrane Peeling for Idiopathic Epiretinal Membrane Surgery: A Randomized Controlled Trial

Idiopathic epiretinal membrane (ERM) is an age-related degenerative retinal condition. One of the primary treatment approaches is vitrectomy combined with epiretinal membrane peeling. However, whether to concurrently perform internal limiting membrane (ILM) peeling remains clinically controversial. Therefore, this study aims to compare the efficacy and safety of performing versus omitting ILM peeling during idiopathic ERM surgery.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eye Center of the Second Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310058, China

Location status: Recruiting

Location contact

Yueyang Zhong

CONTACT

[email protected]

18868125901

About this study

Idiopathic epiretinal membrane (ERM) is an age-related degenerative retinal condition. Its pathological hallmark is the formation of a fibrocellular membrane in the macular region, which can lead to retinal structural distortion and visual impairment. Epidemiological studies indicate that ERM is age-related, occurs more frequently unilaterally, and shows a positive correlation with advancing age, with incidence rates of 2% to 20% in individuals aged 50 to 70 years. The severity primarily depends on the location and thickness of the membrane and the presence of macular pseudoholes, manifesting as symptoms including visual field distortion (metamorphopsia), micropsia, and central vision loss. Studies suggest that ERM patients experiencing progressive visual decline, best-corrected visual acuity (BCVA) ≤ 0.6, or severe metamorphopsia require surgical intervention. There remains a lack of high-quality prospective RCTs evaluating the therapeutic outcomes of vitrectomy combined with ERM peeling with or without ILM peeling in idiopathic ERM patients. Therefore, this study aims to compare the efficacy and safety of performing versus omitting ILM peeling during idiopathic ERM surgery.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients aged >18 years presenting to our hospital within the study period.
  • Patients diagnosed with idiopathic epiretinal membrane (ERM) based on examination.
  • Patients with best-corrected visual acuity (BCVA) ≤ 0.6 or the presence of metamorphopsia.

Exclusion criteria

  • Patients with secondary ERM identified during preoperative evaluation (e.g., secondary to retinal vein occlusion).
  • Patients with concomitant ocular diseases affecting the macula, such as macular degeneration, macular schisis, or macular atrophy.
  • Patients with a history of ocular trauma or previous ocular surgery (except for cataract surgery).
  • Patients with severe systemic diseases contraindicated for surgery.
  • Patients with poor compliance or concomitant psychiatric disorders.
  • Patients who participated in other clinical trials during the follow-up period or who were lost to follow-up.

Treatment and study plan

Epiretinal membrane peeling

Procedure

All patients will receive standard pars plana vitrectomy, followed by only epiretinal membrane peeling.

Epiretinal membrane peeling combined with internal limiting membrane peeling

Procedure

All patients will receive standard pars plana vitrectomy, followed by epiretinal membrane peeling and internal limiting membrane peeling.

Primary outcomes

  1. Mean deviation (MD) value

    Time frame: 6 months postoperatively

    mean deviation (MD) value from postoperative Humphrey visual field testing.

Secondary outcomes

  1. Visual acuity

    Time frame: 6 months postoperatively

    uncorrected and corrected distance visual acuity

  2. Ganglion cell complex

    Time frame: 6 months postoperatively

    Ganglion cell complex parameters on macular OCT

  3. Recurrence rate

    Time frame: 12 months postoperatively

    Recurrence rate of ERM

Study contacts

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

Yueyang Zhong, MD.

CONTACT

[email protected]

+8618868125901

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Aug 27, 2025
Registry last updated
Aug 27, 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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