Amniotic Membrane Associated With Conjunctival Autograft Versus Conjunctival Autograft for Recurrent Pterygia

NCT ID: NCT00802620

Last Updated: 2008-12-05

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

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Brief Summary

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The purpose of this study is to compare amniotic membrane associated with conjunctival autograft versus conjunctival autograft alone in the treatment of recurrent pterygia.

Detailed Description

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Patients with recurrent pterygia without symblepharon were randomly assigned to undertake pterygium excision followed by amniotic membrane associated with a small conjunctival autograft (2x3mm) or conjunctival autograft (approximately 5x8mm) alone. The patients were examined after 1, 7, 30, 90, 180 and 360 days after the surgery. Recurrence was considered as a fibrovascular ingrowth of 1.5 mm or more beyond the limbus with conjunctival drag.

Conditions

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Recurrent Pterygia

Keywords

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Amniotic membrane Conjunctival autograft Recurrent pterygia compare amniotic membrane associated with conjunctival autograft versus conjunctival autograft alone in the treatment of recurrent pterygia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Conjunctival autograft versus conjunctival autograft treatment for recurrent pterygia

Amniotic membrane Conjunctival autograft Conjunctival autograft Recurrent pterygia

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Recurrent pterygium

Exclusion Criteria

* Less than 15 year of age
* Symblepharon
* Glaucoma,
* Ocular Allergy
* Ocular surface disorders
Minimum Eligible Age

15 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Department of Ophthalmology, Federal University of Sao Paulo (UNIFESP), Sao Paulo, Brazil.

Other Identifiers

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0616/04

Identifier Type: -

Identifier Source: org_study_id