Determinants of Pterygium Occurrence and Recurrence in a Rural African Population

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00713180
Recruitment Status : Completed
First Posted : July 11, 2008
Last Update Posted : June 25, 2015
Information provided by:
Anguria, Peter, M.D.

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.

Condition or disease Intervention/treatment Phase
Pterygium Procedure: Pterygium excision followed by grafting Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 355 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Determinants of Pterygium Occurrence and Recurrence in a Rural African Population
Study Start Date : August 2008
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Arm Intervention/treatment
No Intervention: 1
Pterygium free participants
Experimental: 2
Pterygium participants
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

Primary Outcome Measures :
  1. None recurrence of pterygium [ Time Frame: 6 months of follow up after operation ]

Secondary Outcome Measures :
  1. corneal scarring [ Time Frame: 6 months of follow up ]
  2. tenon's granuloma [ Time Frame: 6 months of follow up ]
  3. graft retraction [ Time Frame: one month of follow up ]
  4. Graft haematoma [ Time Frame: one week of follow up ]
  5. Graft hyperaemia [ Time Frame: 3 months of follow up ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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 -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00713180

South Africa
Mankweng Hospital
Polokwane, Limpopo, South Africa, 0727
Sponsors and Collaborators
Anguria, Peter, M.D.
Principal Investigator: Peter Anguria, MMed Mankweng Hospital

Responsible Party: Anguria Peter, Mankweng Hospital Identifier: NCT00713180     History of Changes
Other Study ID Numbers: Research laboratory
First Posted: July 11, 2008    Key Record Dates
Last Update Posted: June 25, 2015
Last Verified: August 2008

Additional relevant MeSH terms:
Disease Attributes
Pathologic Processes
Conjunctival Diseases
Eye Diseases