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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2008 by Federal University of São Paulo.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT00801073
First Posted: December 3, 2008
Last Update Posted: December 3, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Federal University of São Paulo
  Purpose
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 Intervention Phase
Scleral Thinning Procedure: Human Amniotic Membrane Transplantation Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment

Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • 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. [ Time Frame: Patients were followed for 180 days. ]

Enrollment: 49
Study Start Date: February 2005
Primary Completion Date: February 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
No Contacts or Locations Provided
  More Information

Responsible Party: Jose Alvaro Pereira Gomes, Departamento de Oftalmologia/Instituto da Visão, Universidade Federal de São Paulo (UNIFESP), Brazil
ClinicalTrials.gov Identifier: NCT00801073     History of Changes
Other Study ID Numbers: 0060 / 04
First Submitted: December 2, 2008
First Posted: December 3, 2008
Last Update Posted: December 3, 2008
Last Verified: December 2008

Keywords provided by Federal University of São Paulo:
Amniotic membrane
Cornea
Scleral thinning