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OpenTrials
Completed

NCT Number: NCT01250353

The Use of Natural Latex Biomembrane in Ocular Surface Reconstruction

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.

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Key information

Conditions

Conjunctival Diseases Eye Diseases Pterygium

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Erika Christina Canarim Martha de Pinho

Ribeirão Preto, São Paulo, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • symptomatic pterygium

Exclusion criteria

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

Treatment and study plan

pterygium surgery

Procedure

pterygium was removed surgically

Other names: pterygium excision, prevention of pterygium recurrence

Primary outcomes

  1. 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.

Secondary outcomes

  1. pterygium recurrence

    Time frame: twelve months

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

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2009
First posted
Nov 30, 2010
Registry last updated
Nov 30, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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