Clinical Evaluation of With or Without Internal Limiting Membrane Peeling for Idiopathic Epiretinal Membrane Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Mean deviation (MD) value
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
The patients will be masked to the treatment group in this study.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Mean deviation (MD) value
时间窗: 6 months postoperatively
mean deviation (MD) value from postoperative Humphrey visual field testing.
次要结局
- Visual acuity(6 months postoperatively)
- Ganglion cell complex(6 months postoperatively)
- Recurrence rate(12 months postoperatively)