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The Use of Natural Latex Biomembrane in Ocular Surface Reconstruction

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01250353
Enrollment
127
Registered
2010-11-30
Start date
2006-06-30
Completion date
2009-07-31
Last updated
2010-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Conjunctival Diseases, Pterygium

Keywords

ocular surface reconstruction, conjunctival healing, pterygium, latex biomembrane, pterygium surgery

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.

Interventions

pterygium was removed surgically

Sponsors

University of Sao Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* symptomatic pterygium

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
change in fibrovascular tissue growing measuretwelve monthsThe 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

MeasureTime frameDescription
pterygium recurrencetwelve monthsPterygium recurrence was defined like fibrovascular tissue growing up to 1,5mm across the anatomic limbus.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026