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Amniotic Membrane Associated With Conjunctival Autograft Versus Conjunctival Autograft for Recurrent Pterygia

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:
NCT00802620
First Posted: December 5, 2008
Last Update Posted: December 5, 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 compare amniotic membrane associated with conjunctival autograft versus conjunctival autograft alone in the treatment of recurrent pterygia.

Condition Intervention Phase
Recurrent Pterygia Procedure: Conjunctival autograft versus conjunctival autograft treatment for recurrent pterygia Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

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

Primary Outcome Measures:
  • Amniotic membrane treatment for recurrent pterygia [ Time Frame: one year ]

Enrollment: 40
Study Start Date: June 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Conjunctival autograft versus conjunctival autograft treatment for recurrent pterygia
    Amniotic membrane Conjunctival autograft Conjunctival autograft Recurrent pterygia
Detailed Description:
Patients with recurrent pterygia without symblepharon were randomly assigned to undertake pterygium excision followed by amniotic membrane associated with a small conjunctival autograft (2x3mm) or conjunctival autograft (approximately 5x8mm) alone. The patients were examined after 1, 7, 30, 90, 180 and 360 days after the surgery. Recurrence was considered as a fibrovascular ingrowth of 1.5 mm or more beyond the limbus with conjunctival drag.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Recurrent pterygium

Exclusion Criteria:

  • Less than 15 year of age
  • Symblepharon
  • Glaucoma,
  • Ocular Allergy
  • Ocular surface disorders
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Jose Alvaro Pereira Gomes, Department of Ophthalmology, Federal University of Sao Paulo (UNIFESP), Sao Paulo, Brazil.
ClinicalTrials.gov Identifier: NCT00802620     History of Changes
Other Study ID Numbers: 0616/04
First Submitted: December 4, 2008
First Posted: December 5, 2008
Last Update Posted: December 5, 2008
Last Verified: December 2008

Keywords provided by Federal University of São Paulo:
Amniotic membrane
Conjunctival autograft
Recurrent pterygia
compare amniotic membrane associated with conjunctival autograft versus conjunctival autograft alone in the treatment of recurrent pterygia

Additional relevant MeSH terms:
Pterygium
Conjunctival Diseases
Eye Diseases