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

Tracking Information
First Received Date ^ICMJE	December 4, 2008
Last Updated Date	December 4, 2008
Start Date ^ICMJE	June 2005
Primary Completion Date	June 2005 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 4, 2008)	Amniotic membrane treatment for recurrent pterygia [ Time Frame: one year ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Amniotic Membrane Associated With Conjunctival Autograft Versus Conjunctival Autograft for Recurrent Pterygia
Official Title ^ICMJE	Not Provided
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.
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 Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Recurrent Pterygia
Intervention ^ICMJE	Procedure: Conjunctival autograft versus conjunctival autograft treatment for recurrent pterygia Amniotic membrane Conjunctival autograft Conjunctival autograft Recurrent pterygia
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Enrolling by invitation
Enrollment ^ICMJE	40
Completion Date	Not Provided
Primary Completion Date	June 2005 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Recurrent pterygium Exclusion Criteria: Less than 15 year of age Symblepharon Glaucoma, Ocular Allergy Ocular surface disorders
Gender	Both
Ages	15 Years to 80 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00802620
Other Study ID Numbers ^ICMJE	0616/04
Has Data Monitoring Committee	Yes
Responsible Party	Jose Alvaro Pereira Gomes, Department of Ophthalmology, Federal University of Sao Paulo (UNIFESP), Sao Paulo, Brazil.
Study Sponsor ^ICMJE	Federal University of São Paulo
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Federal University of São Paulo
Verification Date	December 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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