The Use of Natural Latex Biomembrane in Ocular Surface Reconstruction

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

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.

Study Overview

• Status: Completed
• Conditions: Conjunctival Diseases; Pterygium
• Intervention / Treatment: Procedure: pterygium surgery

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 Type: Interventional
• Enrollment (Actual): 127
• Phase: Phase 2

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Ribeirão Preto, SP, Brazil
      • Erika Christina Canarim Martha de Pinho

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• symptomatic pterygium

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	twelve months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pterygium recurrence	Pterygium recurrence was defined like fibrovascular tissue growing up to 1,5mm across the anatomic limbus.	twelve months

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Investigators: Study Chair: Sidney JF Sousa, phD, Ribeirão Preto Faculty of Medicine

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start: June 1, 2006
• Primary Completion (Actual): June 1, 2007
• Study Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: November 24, 2010
• First Submitted That Met QC Criteria: November 29, 2010
• First Posted (Estimate): November 30, 2010

Study Record Updates

• Last Update Posted (Estimate): November 30, 2010
• Last Update Submitted That Met QC Criteria: November 29, 2010
• Last Verified: December 1, 2009

More Information

Terms related to this study

• Keywords: pterygium; pterygium surgery; ocular surface reconstruction; conjunctival healing; latex biomembrane
• Additional Relevant MeSH Terms: Eye Diseases; Pterygium; Conjunctival Diseases
• Other Study ID Numbers: 12416/05