This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Determinants of Pterygium Occurrence and Recurrence in a Rural African Population

This study has been completed.
Information provided by:
Anguria, Peter, M.D. Identifier:
First received: July 9, 2008
Last updated: June 24, 2015
Last verified: August 2008

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 Intervention
Pterygium Procedure: Pterygium excision followed by grafting

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Determinants of Pterygium Occurrence and Recurrence in a Rural African Population

Further study details as provided by Anguria, Peter, M.D.:

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

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

Estimated Enrollment: 355
Study Start Date: August 2008
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   21 Years to 65 Years   (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 -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00713180

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

Responsible Party: Anguria Peter, Mankweng Hospital Identifier: NCT00713180     History of Changes
Other Study ID Numbers: Research laboratory
Study First Received: July 9, 2008
Last Updated: June 24, 2015

Additional relevant MeSH terms:
Disease Attributes
Pathologic Processes
Conjunctival Diseases
Eye Diseases processed this record on July 19, 2017