Clinical Trial: The Use of Natural Latex Biomembrane in Ocular Surface Reconstruction

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: University of Sao Paulo

Current Primary Outcome: change in fibrovascular tissue growing measure [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: pterygium recurrence [ Time Frame: twelve months ]

Pterygium recurrence was defined like fibrovascular tissue growing up to 1,5mm across the anatomic limbus.


Original Secondary Outcome: Same as current

Information By: University of Sao Paulo

Dates:
Date Received: November 24, 2010
Date Started: June 2006
Date Completion:
Last Updated: November 29, 2010
Last Verified: December 2009