Comparison Amongst Scleral, Corneal and Amniotic Membrane Grafts to Restore Scleral Thinning

Phase 2

• Conditions: Scleral Thinning
• Interventions: Procedure: Human Amniotic Membrane Transplantation

• Registration Number: NCT00801073
• Lead Sponsor: Federal University of São Paulo

Brief Summary

The purpose of this study is to evaluate the use of preserved scleral, corneal and amniotic membrane graft for the surgical repair of scleral thinning of different sizes in patients underwent surgery of pterygium with associated beta therapy .

Detailed Description

Scleral thinning may occur secondary to different ocular surface conditions, especially in rheumatologic diseases and after surgeries as in pterygium. There are different methods to treat this condition, as to use scleral, corneal and more recently amniotic membrane graft.

Study Timeline

• Study Start: 2005-02
• Primary Completion: 2005-02
• Status Verified: 2008-12
• Study First Submitted: 2008-12-02
• Study First Submitted QC: 2008-12-02
• Last Update Submitted: 2008-12-02
• Study First Posted: 2008-12-03
• Last Update Posted: 2008-12-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

• Patients with corneal scleral defects that have persisted for 1 years or longer, regardless of their cause. These patients will have received corneal-scleral or amniotic membrane transplant in order to correct scleral thinning
• Patients with history of pterygium surgery associated with beta therapy followed by scleral thinning

Exclusion Criteria

• Ocular infection
• Acute ocular inflammatory condition
• Previous ocular surgery in the eye study
• Non-controlled systemic disease such as rheumatoid arthritis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Amniotic Membrane Transplantation	Human Amniotic Membrane Transplantation	Human Amniotic Membrane Transplantation for The Treatment of Ocular Surface Disease

Primary Outcome Measures

Name	Time	Method
The surgical procedure was randomized in scleral, corneal or amniotic membrane graft. Nine patients underwent surgery with scleral graft that was covered by conjunctival flap; ten with corneal graft and ten with amniotic membrane transplantation.	Patients were followed for 180 days.