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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Epiretinal membrane peeling
  All patients will receive standard pars plana vitrectomy, followed by only epiretinal membrane peeling.
• Процедура Epiretinal membrane peeling combined with internal limiting membrane peeling
  All patients will receive standard pars plana vitrectomy, followed by epiretinal membrane peeling and internal limiting membrane peeling.

Первичные конечные точки

• Mean deviation (MD) value [Срок оценки: 6 months postoperatively]

Вторичные конечные точки (3)

• Visual acuity [Срок оценки: 6 months postoperatively]
• Ganglion cell complex [Срок оценки: 6 months postoperatively]
• Recurrence rate [Срок оценки: 12 months postoperatively]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Eye Center of the Second Affiliated Hospital of Zhejiang University — Ханчжоу

Идентификаторы

NCT: NCT07142785 · 20250974

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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