Impact of the Inverted Internal Limiting Membrane Flap Diameter on Idiopathic Macular Hole Closure: Comparative Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- rate of macular hole closure
研究概览
简要总结
In the current study, the investigators described the results of a randomized, comparative clinical trial that was conducted to study the impact of the size of internal limiting membrane (ILM) inverted flap on rate and timing of idiopathic macular hole closure.
详细描述
A prospective randomized comparative study included patients with idiopathic macular hole (MH) attending outpatient clinic.Eligible eyes were divided into 2 groups based on the narrowest diameter of the MH measured by spectral domain optical coherence tomography (SD-OCT). MHs from 250 to 400µm were classified as Medium-sized MHs and MHs > 400 µm were classified as Large-sized MHs. Within each group, eyes were randomly assigned to either small-flap (1-2DD) or large flap (from >2 to 4DD).
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eyes with stage 4 idiopathic MHs with a diameter >250µm on spectral domain optical coherence tomography (SD-OCT)
排除标准
- •traumatic MH
- •myopic MHs,
- •MH secondary to retinal detachment,
- •long-standing MH> 12 months
- •previous retinal surgeries
- •high myopia with an axial length > 26.0 mm
- •other ocular pathologies interfering with the interpretation of the OCT reports.
研究组 & 干预措施
small flap medium-sized macular hole (SFMM)
small flap (1-2 disc-diameter) was performed in medium sized macular hole (250-400 um)
干预措施: pars plana vitrectomy with ILM inverted flap (Procedure)
large flap medium-sized macular hole (LFMM)
large flap (3-4 disc-diameter) was performed in medium sized macular hole (250-400 um)
干预措施: pars plana vitrectomy with ILM inverted flap (Procedure)
small flap large-sized macular hole (SFLM)
small flap (1-2 disc-diameter) was performed in Large sized macular hole (>400 um)
干预措施: pars plana vitrectomy with ILM inverted flap (Procedure)
large flap Large-sized macular hole (LFLM)
large flap (3-4 disc-diameter) was performed in large sized macular hole (>400 um)
干预措施: pars plana vitrectomy with ILM inverted flap (Procedure)
结局指标
主要结局
rate of macular hole closure
时间窗: 6 months
defined as the proportion of the eyes with complete MH closure based on SD-OCT findings
次要结局
- BCVA(6 months)
- timing of MH closure(6 months)