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

This study is enrolling participants by invitation only.

First Received: December 4, 2008 No Changes Posted

Sponsored by:	Federal University of São Paulo
Information provided by:	Federal University of São Paulo
ClinicalTrials.gov Identifier:	NCT00802620

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 I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

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:

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

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Department of Ophthalmology, Federal University of Sao Paulo (UNIFESP), Sao Paulo, Brazil. ( Jose Alvaro Pereira Gomes )
Study ID Numbers:	0616/04
Study First Received:	December 4, 2008
Last Updated:	December 4, 2008
ClinicalTrials.gov Identifier:	NCT00802620 History of Changes
Health Authority:	Brazil: Ethics Committee

Keywords provided by Federal University of São Paulo:

Amniotic membrane
Conjunctival autograft
Conjunctival autograft
Recurrent pterygia
compare amniotic membrane associated with conjunctival autograft versus conjunctival autograft alone in the treatment of recurrent pterygia

Study placed in the following topic categories:

Eye Diseases
Pterygium of the Conjunctiva
Pterygium
Conjunctival Diseases
Recurrence

Additional relevant MeSH terms:

Disease Attributes
Pathologic Processes
Eye Diseases

Pterygium
Conjunctival Diseases
Recurrence

ClinicalTrials.gov processed this record on May 07, 2009