NCT01250353

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
127

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2006

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 24, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 30, 2010

Completed
Last Updated

November 30, 2010

Status Verified

December 1, 2009

Enrollment Period

1 year

First QC Date

November 24, 2010

Last Update Submit

November 29, 2010

Conditions

Conjunctival DiseasesPterygium

Keywords

ocular surface reconstructionconjunctival healingpterygiumlatex biomembranepterygium surgery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • pterygium recurrence

    twelve months

Study Arms (2)

conjunctival autograft

EXPERIMENTAL

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

Procedure: pterygium surgery

latex biomembrane application

EXPERIMENTAL

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

Interventions

pterygium surgeryPROCEDURE

pterygium was removed surgically

Also known as: pterygium excision, prevention of pterygium recurrence
conjunctival autograftlatex biomembrane application

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • symptomatic pterygium

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erika Christina Canarim Martha de Pinho

Ribeirão Preto, São Paulo, Brazil

Location

Related Publications (5)

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

    PMID: 6735650BACKGROUND

  • 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.

    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.

    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.

    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.

    BACKGROUND

MeSH Terms

Conditions

Conjunctival DiseasesPterygium

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

  • Sidney JF Sousa, phD

    Ribeirão Preto Faculty of Medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 24, 2010

First Posted

November 30, 2010

Study Start

June 1, 2006

Primary Completion

June 1, 2007

Study Completion

July 1, 2009

Last Updated

November 30, 2010

Record last verified: 2009-12

Locations

BR(1)