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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT00802620
First received: December 4, 2008
Last updated: NA
Last verified: December 2008
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   15 Years to 80 Years
Genders Eligible for Study:   Both
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
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, 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
Study First Received: December 4, 2008
Last Updated: December 4, 2008
Health Authority: Brazil: Ethics Committee

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

ClinicalTrials.gov processed this record on August 28, 2014