The Use of Natural Latex Biomembrane in Ocular Surface Reconstruction

Study Overview
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Brief Summary
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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 Description
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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.

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

Conditions
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Conjunctival Diseases, Pterygium

Intervention / Treatment
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* Procedure: pterygium surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: symptomatic pterygium Exclusion Criteria: any other ocular surface pathology, glaucoma, retinal disease, pregnancy, auto immune disease, severe systemic disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: conjunctival autograft<br>The conjunctival autograft was performed after the pterygium surgery like usual technique. | Procedure: pterygium surgery<br>* pterygium was removed surgically<br>* Other names: prevention of pterygium recurrence;|
| Experimental: latex biomembrane application<br>The latex biomembrane was applied after pterygium surgery to recover the bare sclera area. This device was closed to conjunctiva with running suture anchored at some places to episclera. The sutures was removed at fourteenth day after surgery. | Procedure: pterygium surgery<br>* pterygium was removed surgically<br>* Other names: prevention of pterygium recurrence;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in fibrovascular tissue growing measure | 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. | twelve months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pterygium recurrence | Pterygium recurrence was defined like fibrovascular tissue growing up to 1,5mm across the anatomic limbus. | twelve months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ocular surface reconstruction, conjunctival healing, pterygium, latex biomembrane, pterygium surgery