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

Federal University of São Paulo

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Scleral Thinning

Treatments: Procedure: Human Amniotic Membrane Transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT00801073

0060 / 04

Details and patient eligibility

About

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 .

Full 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.

Enrollment: 49 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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49 participants in 1 patient group

Amniotic Membrane Transplantation

Experimental group

Description:

Human Amniotic Membrane Transplantation for The Treatment of Ocular Surface Disease

Treatment:

Procedure: Human Amniotic Membrane Transplantation