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

Primary Purpose

Recurrent Pterygia

Status

Unknown status

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

Conjunctival autograft versus conjunctival autograft treatment for recurrent pterygia

About this trial

This is an interventional treatment trial for Recurrent Pterygia focused on measuring Amniotic membrane, Conjunctival autograft, Recurrent pterygia, compare amniotic membrane associated with conjunctival autograft versus conjunctival autograft alone in the treatment of recurrent pterygia

Eligibility Criteria

15 Years - 80 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Recurrent pterygium

Exclusion Criteria:

Less than 15 year of age
Symblepharon
Glaucoma,
Ocular Allergy
Ocular surface disorders

Sites / Locations

Outcomes

Primary Outcome Measures

Amniotic membrane treatment for recurrent pterygia

Secondary Outcome Measures

Full Information

NCT ID

NCT00802620

First Posted

December 4, 2008

Last Updated

December 4, 2008

Sponsor

Federal University of São Paulo

1. Study Identification

Unique Protocol Identification Number

NCT00802620

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2008

Overall Recruitment Status

Unknown status

Study Start Date

June 2005 (undefined)

Primary Completion Date

June 2005 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Federal University of São Paulo

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Recurrent Pterygia

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

Conjunctival autograft versus conjunctival autograft treatment for recurrent pterygia

Intervention Description

Amniotic membrane Conjunctival autograft Conjunctival autograft Recurrent pterygia

Primary Outcome Measure Information:

Title

Amniotic membrane treatment for recurrent pterygia

Time Frame

one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Recurrent pterygium Exclusion Criteria: Less than 15 year of age Symblepharon Glaucoma, Ocular Allergy Ocular surface disorders

12. IPD Sharing Statement

Learn more about this trial

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

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