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Determinants of Pterygium Occurrence and Recurrence in a Rural African Population

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by Anguria, Peter, M.D..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Anguria, Peter, M.D.
ClinicalTrials.gov Identifier:
NCT00713180
First received: July 9, 2008
Last updated: August 7, 2008
Last verified: August 2008

July 9, 2008
August 7, 2008
August 2008
September 2009   (final data collection date for primary outcome measure)
None recurrence of pterygium [ Time Frame: 6 months of follow up after operation ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00713180 on ClinicalTrials.gov Archive Site
  • corneal scarring [ Time Frame: 6 months of follow up ] [ Designated as safety issue: Yes ]
  • tenon's granuloma [ Time Frame: 6 months of follow up ] [ Designated as safety issue: Yes ]
  • graft retraction [ Time Frame: one month of follow up ] [ Designated as safety issue: Yes ]
  • Graft haematoma [ Time Frame: one week of follow up ] [ Designated as safety issue: Yes ]
  • Graft hyperaemia [ Time Frame: 3 months of follow up ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Determinants of Pterygium Occurrence and Recurrence in a Rural African Population
Determinants of Pterygium Occurrence and Recurrence in a Rural African Population

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Pterygium
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
  • No Intervention: 1
    Pterygium free participants
  • Experimental: 2
    Pterygium participants
    Intervention: Procedure: Pterygium excision followed by grafting
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
355
September 2010
September 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Pterygium at least 1.5mm in extent
  2. Both male and female
  3. Age range 21-65 years
  4. Consenting to participate in study
  5. Unilateral and bilateral pterygium
  6. All grades of pterygium

Exclusion Criteria:

  1. Previous cataract, corneoscleral and glaucoma surgery or corneoscleral trauma and corneolimbal scars
  2. Pseudopterygium or signs of malignancy on pterygium
  3. Recurrent pterygium
  4. Sufferers of collagen vascular disease, scleritis or diabetes -
Both
21 Years to 65 Years
Yes
Contact: Peter Anguria, MMed +27765396392 irarak58@gmail.com
South Africa
 
NCT00713180
Research laboratory
Yes
Anguria Peter, Mankweng Hospital
Anguria, Peter, M.D.
Not Provided
Principal Investigator: Peter Anguria, MMed Mankweng Hospital
Anguria, Peter, M.D.
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP