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

Recurrent Pterygia Clinical Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00802620
• Other study ID #: 0616/04
• Status: Enrolling by invitation
• Phase: Phase 1
• First received: December 4, 2008
• Last updated: December 4, 2008
• Start date: June 2005

Study information

• Verified date: December 2008
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. primary completion date: June 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 15 Years to 80 Years

Eligibility

Inclusion Criteria:

• Recurrent pterygium

Exclusion Criteria:

• Less than 15 year of age

• Symblepharon

• Glaucoma,

• Ocular Allergy

• Ocular surface disorders

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pterygium
• Recurrent Pterygia

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amniotic membrane treatment for recurrent pterygia		one year	Yes