Comparison Amongst Scleral, Corneal and Amniotic Membrane Grafts to Restore Scleral Thinning

Scleral Thinning Clinical Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00801073
• Other study ID #: 0060 / 04
• Status: Enrolling by invitation
• Phase: Phase 2/Phase 3
• First received: December 2, 2008
• Last updated: December 2, 2008
• Start date: February 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 evaluate the use of preserved scleral, corneal and amniotic membrane graft for the surgical repair of scleral thinning of different sizes in patients underwent surgery of pterygium with associated beta therapy .

Description:

Scleral thinning may occur secondary to different ocular surface conditions, especially in rheumatologic diseases and after surgeries as in pterygium. There are different methods to treat this condition, as to use scleral, corneal and more recently amniotic membrane graft.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 49
• Est. primary completion date: February 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients with corneal scleral defects that have persisted for 1 years or longer, regardless of their cause. These patients will have received corneal-scleral or amniotic membrane transplant in order to correct scleral thinning

• Patients with history of pterygium surgery associated with beta therapy followed by scleral thinning

Exclusion Criteria:

• Ocular infection

• Acute ocular inflammatory condition

• Previous ocular surgery in the eye study

• Non-controlled systemic disease such as rheumatoid arthritis

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Scleral Thinning

Intervention

Procedure:
• Human Amniotic Membrane Transplantation
Human Amniotic Membrane Transplantation for The Treatment of Ocular Surface Disease

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	The surgical procedure was randomized in scleral, corneal or amniotic membrane graft. Nine patients underwent surgery with scleral graft that was covered by conjunctival flap; ten with corneal graft and ten with amniotic membrane transplantation.		Patients were followed for 180 days.	Yes