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The Use of Natural Latex Biomembrane in Ocular Surface Reconstruction

NCT ID: NCT01250353

Last Updated: 2010-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

127 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2009-07-31

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.

Conditions

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Conjunctival Diseases Pterygium

Keywords

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ocular surface reconstruction conjunctival healing pterygium latex biomembrane pterygium surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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conjunctival autograft

The conjunctival autograft was performed after the pterygium surgery like usual technique.

Group Type EXPERIMENTAL

pterygium surgery

Intervention Type PROCEDURE

pterygium was removed surgically

latex biomembrane application

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.

Group Type EXPERIMENTAL

pterygium surgery

Intervention Type PROCEDURE

pterygium was removed surgically

Interventions

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pterygium surgery

pterygium was removed surgically

Intervention Type PROCEDURE

Other Intervention Names

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pterygium excision prevention of pterygium recurrence

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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RIbeirão Preto Faculty of Medicine

Principal Investigators

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Sidney JF Sousa, phD

Role: STUDY_CHAIR

Ribeirão Preto Faculty of Medicine

Locations

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Erika Christina Canarim Martha de Pinho

Ribeirão Preto, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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Geggel HS, Friend J, Thoft RA. Conjunctival epithelial wound healing. Invest Ophthalmol Vis Sci. 1984 Jul;25(7):860-3.

Reference Type BACKGROUND
PMID: 6735650 (View on PubMed)

PINHO, E.C.C.M. Uso de uma membrana derivada de látex natural na superfície ocular. Estudo experimental em coelhos. Dissertação. (Mestrado em Oftalmolgia). Ribeirão Preto, Universidade de São Paulo, 2003. p 96.

Reference Type BACKGROUND

PINHO, E.C.C.M.; FARIA E SOUSA, S.J.; CHAHUD, F.; LACHAT, J-J.; COUTINHO - NETTO, J. Uso experimental da biomembrana de látex na reconstrução conjuntival. Arquivos Brasileiros de Oftalmologia, v. 67, p. 27- 32, 2004.

Reference Type BACKGROUND

PINHO, E.C.C.M.; SEIXAS, G.C.O.; SOUZA-JUNIOR, E.N.; FARIA E SOUSA, S.J.; LACHAT, J-J.; COUTINHO - NETTO, J. The use of natural latex in human eye: technique description. In: Congresso Mundial de Oftalmologia, 2006a, São Paulo. Anais eletrônicos, código 2717.

Reference Type BACKGROUND

PINHO, E.C.C.M; FARIA E SOUSA, S.J.; SOUZA-JUNIOR, E.N.; SEIXAS, G.C.O.; LACHAT, J-J.; COUTINHO - NETTO, J. The use of natural latex in ocular surface, like tissue repair promoter, in pterygium excision. In: Congresso Mundial de Oftalmologia, 2006b, São Paulo. Anais eletrônicos, código 2150.

Reference Type BACKGROUND

Other Identifiers

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12416/05

Identifier Type: -

Identifier Source: org_study_id