The Use of Natural Latex Biomembrane in Ocular Surface Reconstruction

Phase 2

Completed

• Conditions: Pterygium; Conjunctival Diseases
• Interventions: Procedure: pterygium surgery

• Registration Number: NCT01250353
• Lead Sponsor: University of Sao Paulo

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 Description

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.

Study Timeline

• Study Start: 2006-06
• Primary Completion: 2007-06
• Study Completion: 2009-07
• Status Verified: 2009-12
• Study First Submitted: 2010-11-24
• Study First Submitted QC: 2010-11-29
• Last Update Submitted: 2010-11-29
• Study First Posted: 2010-11-30
• Last Update Posted: 2010-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 127

Inclusion Criteria

• symptomatic pterygium

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conjunctival autograft	pterygium surgery	The conjunctival autograft was performed after the pterygium surgery like usual technique.
latex biomembrane application	pterygium surgery	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.

Primary Outcome Measures

Name	Time	Method
change in fibrovascular tissue growing measure	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 Outcome Measures

Name	Time	Method
pterygium recurrence	twelve months	Pterygium recurrence was defined like fibrovascular tissue growing up to 1,5mm across the anatomic limbus.

Trial Locations

Locations (1)

Erika Christina Canarim Martha de Pinho; 🇧🇷 Ribeirão Preto, SP, Brazil