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临床试验/NCT03525899
NCT03525899已完成不适用

Macular Hole After Diabetic Vitrectomy

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2017年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
7
试验地点
1
主要终点
Time to macular hole closure

研究概览

简要总结

To present the clinical characteristics and rational treatment of macular hole (MH) after the diabetic vitrectomy (DV) in patients with proliferative diabetic retinopathy (PDR).

详细描述

All patients had received initial vitrectomy to treat complications of PDR. Recruited patients were divided to two groups: the persistent MH group, who had MH before the primary DV (group 1); and the newly-developed MH group, who developed MH after a successful primary DV (group 2). The patients' demographic data, records of ophthalmological examinations, and surgical procedures were collected, including best-corrected visual acuity before and after each operation, fundus changes, as well as MH repairing techniques. The extent of fibrovascular proliferation(FVP) was separated into four grades based on the severity of vitreoretinal adhesion : multiple-point adhesions with or without one site plaque-like broad adhesion (grade 1), broad adhesions in more than one but fewer than three sites, located posterior to the equator (grade 2), broad adhesions in more than three sites, located posterior to the equator or extending beyond the equator within one quadrant (grade 3), and broad adhesions extending beyond the equator for more than one quadrant (grade 4). The extent of retinal detachment (RD) was classified into "within the arcade" or "beyond the arcade". The macular structure was evaluated by optical coherence tomography (OCT). All patients had a follow-up duration of more than three months after the final surgical procedures.

Three different surgical techniques were used to treat MH: standard internal limiting membrane (ILM) peeling, inverted ILM flap insertion into the MH, and lens anterior or posterior capsular flap insertion into the MH. The indication(s) for each technique were:

standard ILM peeling was performed if no ILM peeling had been done in the previous surgery, and the MH size was less than 500um in an attached retina; inverted ILM flap insertion was performed if no ILM peeling had been done in the previous surgery, with a detached retina; lens anterior capsule flap insertion was performed if cataract surgery was performed in the same setting with no ILM tissue available; lens posterior capsule flap insertion was performed in a pseudophakic eye with no ILM tissue available. Only descriptive statistics was obtained.

研究设计

研究类型
Observational
观察模型
Case Only
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

  • Proliferative diabetic retinopathy patients presenting with macular hole after primary diabetic vitrectomy
  • The persistent MH group after surgery, who had MH before the primary DV
  • Newly-developed MH group, who developed MH after a successful primary diabetic retinopathy

排除标准

  • Patients with peripheral breaks
  • Patients with macular hole before surgery, which closed after primary diabetic retinopathy
  • Missing clinical data

结局指标

主要结局

Time to macular hole closure

时间窗: OCT was performed monthly after operation, until MH closure was achieved, up yo 1 year

Evaluation by optical coherence tomography

次要结局

  • Best corrected visual acuity(One month after operation, and then the visual acuity was checked every six months. Up to 3.5 years.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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