NCT02930369已完成4 期
A Randomized, Comparative, Prospective Study of Anatomical Outcomes With Different Internal Limiting Membrane Peeling Area in Surgery for Idiopathic Macular Hole
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 128
- 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 (ILM) peeling area on anatomical closure outcomes after macular hole surgery measured by optical coherence tomography (OCT).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- — 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with IMH
- •patients signed the informed consent form (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: 1 year
次要结局
- Change of anatomical closure grades in OCT(3 months, 6 months, 1 year)
- Change from baseline in BCVA (best corrected visual acuity)(3 months, 6 months, 1 year)
研究者
Mingwei Zhao
Dr.
Peking University People's Hospital
相似试验
Unknown
4 期
Study of Surgery in Patients With Idiopathic Macular HoleSurgeryIdiopathic Macular HoleNCT02905409Peking University People's Hospital228
已完成
不适用
ILM Inverted Flap Size in Macular HoleIdiopathic Macular HoleNCT04683276Mansoura University42
招募中
不适用
Comparison between internal limiting membrane inverted flap and graft techniques for idiopathic large macular holesEye DiseasesMacular holePACTR201712002858314Authors40
Unknown
不适用
Clinical Research on the Effect of Different Extents of Internal Limiting Membrane Peeling on Macular Hole Closure and Visual AcuityMacular HolesNCT03805763Wenzhou Medical University60
招募中
Unknown
Comparison of macular detachment surgery with ILM flap in retinal hole treatmentMacular hole.Macular cyst, hole, or pseudoholeH35.34IRCT20230226057539N1Esfahan University of Medical Sciences30