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
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 355
Study Start Date: August 2008
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: September 2009 (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

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 ClinicalTrials.gov identifier: NCT00713180

Contacts
Contact: Peter Anguria, MMed +27765396392 irarak58@gmail.com

Locations
South Africa
Mankweng Hospital Recruiting
Polokwane, Limpopo, South Africa, 0727
Contact: Peter Anguria, MMed    +27765396392    irarak58@gmail.com   
Principal Investigator: Peter Anguria, MMed         
Sponsors and Collaborators
Anguria, Peter, M.D.
Investigators
Principal Investigator: Peter Anguria, MMed Mankweng Hospital
  More Information

No publications provided

Responsible Party: Anguria Peter, Mankweng Hospital
ClinicalTrials.gov Identifier: NCT00713180     History of Changes
Other Study ID Numbers: Research laboratory
Study First Received: July 9, 2008
Last Updated: August 7, 2008
Health Authority: South Africa: National Health Research Ethics Council

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

ClinicalTrials.gov processed this record on September 18, 2014