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

NCT ID: NCT00801073

Last Updated: 2008-12-03

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

PHASE2/PHASE3

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Brief Summary

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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

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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.

Conditions

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Scleral Thinning

Keywords

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Amniotic membrane Cornea Scleral thinning

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Amniotic Membrane Transplantation

Human Amniotic Membrane Transplantation for The Treatment of Ocular Surface Disease

Group Type EXPERIMENTAL

Human Amniotic Membrane Transplantation

Intervention Type PROCEDURE

Human Amniotic Membrane Transplantation for The Treatment of Ocular Surface Disease

Interventions

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Human Amniotic Membrane Transplantation

Human Amniotic Membrane Transplantation for The Treatment of Ocular Surface Disease

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Departamento de Oftalmologia/Instituto da Visão, Universidade Federal de São Paulo (UNIFESP), Brazil

Other Identifiers

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0060 / 04

Identifier Type: -

Identifier Source: org_study_id