The Use of Natural Latex Biomembrane in Ocular Surface Reconstruction

This study has been completed.
Sponsor:
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01250353
First received: November 24, 2010
Last updated: November 29, 2010
Last verified: December 2009
  Purpose

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.


Condition Intervention Phase
Conjunctival Diseases
Pterygium
Procedure: pterygium surgery
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Use of Natural Latex Biomembrane in Ocular Surface Reconstruction and Pterygium

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • change in fibrovascular tissue growing measure [ Time Frame: twelve months ] [ Designated as safety issue: No ]
    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:
  • pterygium recurrence [ Time Frame: twelve months ] [ Designated as safety issue: No ]
    Pterygium recurrence was defined like fibrovascular tissue growing up to 1,5mm across the anatomic limbus.


Enrollment: 127
Study Start Date: June 2006
Study Completion Date: July 2009
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: conjunctival autograft
The conjunctival autograft was performed after the pterygium surgery like usual technique.
Procedure: pterygium surgery
pterygium was removed surgically
Other Names:
  • pterygium excision
  • prevention of pterygium recurrence
Experimental: 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.
Procedure: pterygium surgery
pterygium was removed surgically
Other Names:
  • pterygium excision
  • prevention of pterygium recurrence

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • symptomatic pterygium

Exclusion Criteria:

  • any other ocular surface pathology, glaucoma, retinal disease, pregnancy, auto immune disease, severe systemic disease
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01250353

Locations
Brazil
Erika Christina Canarim Martha de Pinho
Ribeirão Preto, SP, Brazil
Sponsors and Collaborators
University of Sao Paulo
Investigators
Study Chair: Sidney JF Sousa, phD Ribeirão Preto Faculty of Medicine
  More Information

Publications:
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.

Responsible Party: Erika Christina Canarim Martha de Pinho, RIbeirão Preto Faculty of Medicine
ClinicalTrials.gov Identifier: NCT01250353     History of Changes
Other Study ID Numbers: 12416/05
Study First Received: November 24, 2010
Last Updated: November 29, 2010
Health Authority: Brazil: Ethics Committee
Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
ocular surface reconstruction
conjunctival healing
pterygium
latex biomembrane
pterygium surgery

Additional relevant MeSH terms:
Conjunctival Diseases
Pterygium
Eye Diseases

ClinicalTrials.gov processed this record on October 29, 2014