Determinants of Pterygium Occurrence and Recurrence in a Rural African Population
1 other identifier
interventional
355
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2008
Longer than P75 for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
July 9, 2008
CompletedFirst Posted
Study publicly available on registry
July 11, 2008
CompletedStudy Start
First participant enrolled
August 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedJune 25, 2015
August 1, 2008
3.5 years
July 9, 2008
June 24, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
None recurrence of pterygium
6 months of follow up after operation
Secondary Outcomes (5)
corneal scarring
6 months of follow up
tenon's granuloma
6 months of follow up
graft retraction
one month of follow up
Graft haematoma
one week of follow up
Graft hyperaemia
3 months of follow up
Study Arms (2)
1
NO INTERVENTIONPterygium free participants
2
EXPERIMENTALPterygium participants
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 -
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mankweng Hospital
Polokwane, Limpopo, 0727, South Africa
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Anguria, MMed
Mankweng Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDIV
Study Record Dates
First Submitted
July 9, 2008
First Posted
July 11, 2008
Study Start
August 1, 2008
Primary Completion
February 1, 2012
Study Completion
February 1, 2012
Last Updated
June 25, 2015
Record last verified: 2008-08