A Randomized, Double-masked, Multicenter, Controlled Study of Effects of Internal Membrane Peeling Surgery in Patients With Idiopathic Macular Hole Measured by Optical Coherence Tomography.
试验速览
- 阶段
- 4 期
- 入组人数
- 228
- 试验地点
- 1
- 主要终点
- Anatomical closure grades in OCT
研究概览
简要总结
The purpose of this study is to determine the effects of two different internal limiting membrane peeling with distinct diameters after macular hole surgery on anatomical closure grades.
详细描述
The purpose of this study is to investigate two distinct diameter of internal limiting membrane peeling on anatomical outcomes of macular hole surgery with different preoperative idiopathic macular hole.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with IMH
- •patients signed the ICF
- •patients with course of IMH less than 3 years
排除标准
- •patients with hyper myopia
- •patients with traumatic macular hole
- •accompanied or secondary of other fundus disease
- •open or reopen after receiving MH surgery
- •patients with retinal detachment
- •received vitrectomy due to other diseases
- •glaucoma cannot be controled by medication
- •patients with other retinal or choroidal disease that may affect VA
- •poor patients compliance
- •poor condition that cannot undertake the surgery
- •dioptric media opacities which make it difficult to exam fundus or measure on OCT
结局指标
主要结局
Anatomical closure grades in OCT
时间窗: 6 months
The anatomical outcomes were defined as good closure and poor closure.
Change of anatomical closure grades in OCT
时间窗: 1 month, 3 months, 6 months, 1 year
The anatomical outcomes were defined as good closure and poor closure.
次要结局
- Change from baseline in BCVA (best corrected visual acuity).(1 month, 3 months, 6 months, 1 year)
研究者
Mingwei Zhao
Head of Opthalmology Department, Principal Investigator, Clinical Professor
Peking University People's Hospital