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临床试验/NCT01250353
NCT01250353已完成2 期

The Use of Natural Latex Biomembrane in Ocular Surface Reconstruction and Pterygium

University of Sao Paulo1 个研究点 分布在 1 个国家目标入组 127 人开始时间: 2006年6月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
127
试验地点
1
主要终点
change in fibrovascular tissue growing measure

研究概览

简要总结

The main problem of ocular surface reconstruction is the lack of viable conjunctival tissue. The use of a biocompatible latex biomembrane in ocular surface healing, like post pterygium surgery, could be an alternative therapeutic resource to this process.

详细描述

The latex biomembrane is considered biocompatible and believed to promote neoformation of biological tissues. It also induces vascular neoformation and promotes extra cellular provisional matrix formation, fundamental steps for any kind of wound healing. In humans, it was successfully used in chronic cutaneous ulcer and otologic surgeries. In rabbits' eyes, the latex biomembrane was efficient in ocular surface reconstruction with adequate conjunctiva functional recovery, compared to bare sclera. To study the latex biomembrane action in human ocular surface, it was compared to conjunctival autograft in humans eyes. Considering the deficiency of adequate sized groups and the pterygium recurrences criteria differences, this study proposes the fibrovascular tissue growing measure like an auxiliary method of pos-operative evaluation. The biomembrane of natural latex seems to be efficient in ocular surface reconstruction and must be employed in future studies of other ocular pathologies. This material revealed to be a new source of therapeutic resort to external eye diseases and conjunctival replace in surgeries living bare sclera.

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
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • symptomatic pterygium

排除标准

  • any other ocular surface pathology, glaucoma, retinal disease, pregnancy, auto immune disease, severe systemic disease

结局指标

主要结局

change in fibrovascular tissue growing measure

时间窗: twelve months

The fibrovascular tissue growing measure was designed to be an auxiliary method of pos-operative evaluation. At the slit lamp, the pterygium or the fibrovascular growing tissue was measured related to anatomic limbus. To the scleral side was given negative value and to the cornea side was given positive value. The anatomic limbus was the zero in this scale. The results were compared at inicial stage and three, six and twelve months, to evaluate the progression and recurrence probability.

次要结局

  • pterygium recurrence(twelve months)

研究者

申办方类型
Other

研究点 (1)

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