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

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ClinicalTrials.gov Identifier: NCT00802620
Recruitment Status : Unknown
Verified December 2008 by Federal University of São Paulo.
Recruitment status was:  Enrolling by invitation
First Posted : December 5, 2008
Last Update Posted : December 5, 2008
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Recurrent Pterygia Procedure: Conjunctival autograft versus conjunctival autograft treatment for recurrent pterygia Phase 1

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : June 2005
Primary Completion Date : June 2005
Arms and Interventions

Intervention Details:
    Procedure: Conjunctival autograft versus conjunctival autograft treatment for recurrent pterygia
    Amniotic membrane Conjunctival autograft Conjunctival autograft Recurrent pterygia

Outcome Measures

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

Eligibility Criteria

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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
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 Posted: December 5, 2008    Key Record Dates
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