Comparison Amongst Scleral, Corneal and Amniotic Membrane Grafts to Restore Scleral Thinning
1 other identifier
interventional
49
0 countries
N/A
Brief 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 .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2005
CompletedFirst Submitted
Initial submission to the registry
December 2, 2008
CompletedFirst Posted
Study publicly available on registry
December 3, 2008
CompletedDecember 3, 2008
December 1, 2008
Same day
December 2, 2008
December 2, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Study Arms (1)
Amniotic Membrane Transplantation
EXPERIMENTALHuman Amniotic Membrane Transplantation for The Treatment of Ocular Surface Disease
Interventions
Human Amniotic Membrane Transplantation for The Treatment of Ocular Surface Disease
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Ocular infection
- Acute ocular inflammatory condition
- Previous ocular surgery in the eye study
- Non-controlled systemic disease such as rheumatoid arthritis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 2, 2008
First Posted
December 3, 2008
Study Start
February 1, 2005
Primary Completion
February 1, 2005
Last Updated
December 3, 2008
Record last verified: 2008-12