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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT00801073
First received: December 2, 2008
Last updated: NA
Last verified: December 2008
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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. ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

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
Study First Received: December 2, 2008
Last Updated: December 2, 2008
Health Authority: Brazil: Ethics Committee

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

ClinicalTrials.gov processed this record on September 14, 2014