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临床试验/NCT01687829
NCT01687829Unknown不适用

Macular Hole Surgery With and Without Internal Limiting Membrane Peeling:A Systematic Review and Meta-analysis

Yifan Feng1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2013年1月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
400
试验地点
1
主要终点
Anatomic Success rate

研究概览

简要总结

Since Kelly and Wendel first reported successful closure of idiopathic macular holes (MH) by vitrectomy in 1991, many surgical modifications have been made to improve the anatomical and visual outcomes of this surgery. Recently, internal limiting membrane (ILM) peeling has become used widely as an adjunctive procedure during MH surgery because the removal of ILM is thought to reduce the tangential traction on the macula, a major factor in the pathogenesis of idiopathic macular holes. However, the role of ILM peeling in macular hole surgery is not yet well defined. To the best of our knowledge, there is no meta-analysis on comparison of the efficacy of ILM peeling and suture for MH surgery. This study reviewed the published literature comparing surgical results with and without ILM peeling and and performed a meta-analysis to determine whether there is any benefit or detriment anatomically and/or visually.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Eligible participants are those with idiopathic FTMH in stages 2-3, of less or equal than 18 months duration (based on symptoms reported by the patient) and with a visual acuity equal to or worse than 20/40 in the study eye.

排除标准

  • Patients with idiopathic FTMH stages 2-3 but longer than 18 months duration or with other causes of decreased vision (e.g. corneal scarring, age-related macular degeneration, diabetic retinopathy, glaucoma if central and/or paracentral absolute visual field defects are present) and
  • Those with FTMH related to high myopia (> 6 dioptres) or trauma will be excluded from the study.

结局指标

主要结局

Anatomic Success rate

时间窗: 12 months

Anatomic success defined as a closed hole without a visible edge or a flat hole without a rim of subretinal fluid.

Functional Success Rate

时间窗: 12 month

Functional Success defined as an improvement of 2 or more Snellen BCVA.

次要结局

  • Best-corrected visual acuity(12 month)
  • Complications(12 months)

研究者

发起方
Yifan Feng
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yifan Feng

Eye Hospital, Wenzhou Medical College, China

Wenzhou Medical University

研究点 (1)

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