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

NCT ID: NCT00802620

Last Updated: 2008-12-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-06-30

Brief Summary

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

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

Recurrent Pterygia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Conjunctival autograft versus conjunctival autograft treatment for recurrent pterygia

Amniotic membrane Conjunctival autograft Conjunctival autograft Recurrent pterygia

Intervention Type: PROCEDURE

Eligibility Criteria

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

Federal University of São Paulo

OTHER

Sponsor Role: lead

Responsible Party

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

Other Identifiers

0616/04

Identifier Type: -

Identifier Source: org_study_id