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The Use of Natural Latex Biomembrane in Ocular Surface Reconstruction

Primary Purpose

Conjunctival Diseases, Pterygium

Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
pterygium surgery
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Conjunctival Diseases focused on measuring ocular surface reconstruction, conjunctival healing, pterygium, latex biomembrane, pterygium surgery

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • symptomatic pterygium

Exclusion Criteria:

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

Sites / Locations

  • Erika Christina Canarim Martha de Pinho

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

conjunctival autograft

latex biomembrane application

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
November 24, 2010
Last Updated
November 29, 2010
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01250353
Brief Title
The Use of Natural Latex Biomembrane in Ocular Surface Reconstruction
Official Title
The Use of Natural Latex Biomembrane in Ocular Surface Reconstruction and Pterygium
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Conjunctival Diseases, Pterygium
Keywords
ocular surface reconstruction, conjunctival healing, pterygium, latex biomembrane, pterygium surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
127 (Actual)

8. Arms, Groups, and Interventions

Arm Title
conjunctival autograft
Arm Type
Experimental
Arm Description
The conjunctival autograft was performed after the pterygium surgery like usual technique.
Arm Title
latex biomembrane application
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
pterygium surgery
Other Intervention Name(s)
pterygium excision, prevention of pterygium recurrence
Intervention Description
pterygium was removed surgically
Primary Outcome Measure Information:
Title
change in fibrovascular tissue growing measure
Description
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.
Time Frame
twelve months
Secondary Outcome Measure Information:
Title
pterygium recurrence
Description
Pterygium recurrence was defined like fibrovascular tissue growing up to 1,5mm across the anatomic limbus.
Time Frame
twelve months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: symptomatic pterygium Exclusion Criteria: any other ocular surface pathology, glaucoma, retinal disease, pregnancy, auto immune disease, severe systemic disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sidney JF Sousa, phD
Organizational Affiliation
Ribeirão Preto Faculty of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Erika Christina Canarim Martha de Pinho
City
Ribeirão Preto
State/Province
SP
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
6735650
Citation
Geggel HS, Friend J, Thoft RA. Conjunctival epithelial wound healing. Invest Ophthalmol Vis Sci. 1984 Jul;25(7):860-3.
Results Reference
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Citation
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.
Results Reference
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Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
Citation
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.
Results Reference
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The Use of Natural Latex Biomembrane in Ocular Surface Reconstruction

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