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临床试验/NCT00801073
NCT00801073Unknown2 期

Comparison Amongst Scleral, Corneal and Amniotic Membrane Grafts to Restore Scleral Thinning

Federal University of São Paulo0 个研究点目标入组 49 人开始时间: 2005年2月1日最近更新:
适应症

试验速览

阶段
2 期
发起方
入组人数
49
主要终点
The surgical procedure was randomized in scleral, corneal or amniotic membrane graft. Nine patients underwent surgery with scleral graft that was covered by conjunctival flap; ten with corneal graft and ten with amniotic membrane transplantation.

研究概览

简要总结

The purpose of this study is to evaluate the use of preserved scleral, corneal and amniotic membrane graft for the surgical repair of scleral thinning of different sizes in patients underwent surgery of pterygium with associated beta therapy .

详细描述

Scleral thinning may occur secondary to different ocular surface conditions, especially in rheumatologic diseases and after surgeries as in pterygium. There are different methods to treat this condition, as to use scleral, corneal and more recently amniotic membrane graft.

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
Single (Participant)

入排标准

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

入选标准

  • Patients with corneal scleral defects that have persisted for 1 years or longer, regardless of their cause. These patients will have received corneal-scleral or amniotic membrane transplant in order to correct scleral thinning
  • Patients with history of pterygium surgery associated with beta therapy followed by scleral thinning

排除标准

  • Ocular infection
  • Acute ocular inflammatory condition
  • Previous ocular surgery in the eye study
  • Non-controlled systemic disease such as rheumatoid arthritis

结局指标

主要结局

The surgical procedure was randomized in scleral, corneal or amniotic membrane graft. Nine patients underwent surgery with scleral graft that was covered by conjunctival flap; ten with corneal graft and ten with amniotic membrane transplantation.

时间窗: Patients were followed for 180 days.

次要结局

未报告次要终点

研究者

发起方
Federal University of São Paulo
申办方类型
Other

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