Determinants of Pterygium Occurrence and Recurrence in a Rural African Population
Recruitment status was Recruiting
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | July 9, 2008 | ||||
| Last Updated Date | August 7, 2008 | ||||
| Start Date ICMJE | August 2008 | ||||
| Estimated Primary Completion Date | September 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
None recurrence of pterygium [ Time Frame: 6 months of follow up after operation ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00713180 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
|
||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Determinants of Pterygium Occurrence and Recurrence in a Rural African Population | ||||
| Official Title ICMJE | Determinants of Pterygium Occurrence and Recurrence in a Rural African Population | ||||
| 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. |
||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Prevention |
||||
| Condition ICMJE | Pterygium | ||||
| Intervention ICMJE | Procedure: Pterygium excision followed by grafting
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 |
||||
| Study Arm (s) |
|
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 355 | ||||
| Estimated Completion Date | September 2010 | ||||
| Estimated Primary Completion Date | September 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 21 Years to 65 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
|
||||
| Location Countries ICMJE | South Africa | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00713180 | ||||
| Other Study ID Numbers ICMJE | Research laboratory | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Anguria Peter, Mankweng Hospital | ||||
| Study Sponsor ICMJE | Anguria, Peter, M.D. | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Anguria, Peter, M.D. | ||||
| Verification Date | August 2008 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||