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

• Sponsor: Federal University of São Paulo (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00801073
• Collaborator: (none)
• Enrollment: 49
• Arm: 1

Study Details

Study Description

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 .

Condition or Disease	Intervention/Treatment	Phase
Scleral Thinning	Procedure: Human Amniotic Membrane Transplantation	Phase 2/Phase 3

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 Design

• Study Type: Interventional
• Actual Enrollment: 49 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Study Start Date: Feb 1, 2005
• Actual Primary Completion Date: Feb 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Amniotic Membrane Transplantation Human Amniotic Membrane Transplantation for The Treatment of Ocular Surface Disease	Procedure: Human Amniotic Membrane Transplantation; Human Amniotic Membrane Transplantation for The Treatment of Ocular Surface Disease

Outcome Measures

Primary Outcome Measures

1. 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.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Federal University of São Paulo

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00801073
• Other Study ID Numbers: 0060 / 04
• First Posted: Dec 3, 2008
• Last Update Posted: Dec 3, 2008
• Last Verified: Dec 1, 2008

• Keywords provided by , ,: Amniotic membrane; Cornea; Scleral thinning

Study Results

No Results Posted as of Dec 3, 2008