Determinants of Pterygium Occurrence and Recurrence in a Rural African Population
Primary Purpose
Pterygium
Status
Completed
Phase
Not Applicable
Locations
South Africa
Study Type
Interventional
Intervention
Pterygium excision followed by grafting
Sponsored by
About this trial
This is an interventional prevention trial for Pterygium
Eligibility Criteria
Inclusion Criteria:
- Pterygium at least 1.5mm in extent
- Both male and female
- Age range 21-65 years
- Consenting to participate in study
- Unilateral and bilateral pterygium
- All grades of pterygium
Exclusion Criteria:
- Previous cataract, corneoscleral and glaucoma surgery or corneoscleral trauma and corneolimbal scars
- Pseudopterygium or signs of malignancy on pterygium
- Recurrent pterygium
- Sufferers of collagen vascular disease, scleritis or diabetes -
Sites / Locations
- Mankweng Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
1
2
Arm Description
Pterygium free participants
Pterygium participants
Outcomes
Primary Outcome Measures
None recurrence of pterygium
Secondary Outcome Measures
corneal scarring
tenon's granuloma
graft retraction
Graft haematoma
Graft hyperaemia
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00713180
Brief Title
Determinants of Pterygium Occurrence and Recurrence in a Rural African Population
Official Title
Determinants of Pterygium Occurrence and Recurrence in a Rural African Population
Study Type
Interventional
2. Study Status
Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Anguria, Peter, M.D.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of the study is to find out why pterygium occurs and recurs in a rural African population. Participants will be interviewed on personal and lifestyle information, family history of pterygium, environmental exposure and history of previous eye inflammation. They will undergo eye examination and photography. Those with pterygium will be operated on to remove pterygium and followed up to detect any recurrence and complications of surgery. The excised pterygium will be examined pathologically and genetically; participant's blood will also be examined genetically. Data will be analyzed for statistically significant differences in findings between pterygium and pterygium free participants.
The study hypothesis is that multiple factors are responsible for the occurrence and recurrence of pterygium in a rural african population.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pterygium
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
355 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
No Intervention
Arm Description
Pterygium free participants
Arm Title
2
Arm Type
Experimental
Arm Description
Pterygium participants
Intervention Type
Procedure
Intervention Name(s)
Pterygium excision followed by grafting
Intervention Description
Pterygium will be excised followed by either free conjunctival or limbal conjunctival graft obtained from the upper part of the globe. The graft will be kept in place by sutures
Primary Outcome Measure Information:
Title
None recurrence of pterygium
Time Frame
6 months of follow up after operation
Secondary Outcome Measure Information:
Title
corneal scarring
Time Frame
6 months of follow up
Title
tenon's granuloma
Time Frame
6 months of follow up
Title
graft retraction
Time Frame
one month of follow up
Title
Graft haematoma
Time Frame
one week of follow up
Title
Graft hyperaemia
Time Frame
3 months of follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Pterygium at least 1.5mm in extent
Both male and female
Age range 21-65 years
Consenting to participate in study
Unilateral and bilateral pterygium
All grades of pterygium
Exclusion Criteria:
Previous cataract, corneoscleral and glaucoma surgery or corneoscleral trauma and corneolimbal scars
Pseudopterygium or signs of malignancy on pterygium
Recurrent pterygium
Sufferers of collagen vascular disease, scleritis or diabetes -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Anguria, MMed
Organizational Affiliation
Mankweng Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mankweng Hospital
City
Polokwane
State/Province
Limpopo
ZIP/Postal Code
0727
Country
South Africa
12. IPD Sharing Statement
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Determinants of Pterygium Occurrence and Recurrence in a Rural African Population
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