Determinants of Pterygium Occurrence and Recurrence in a Rural African Population - Full Text View

Sponsored by:	Anguria, Peter, M.D.
Information provided by:	Anguria, Peter, M.D.
ClinicalTrials.gov Identifier:	NCT00713180

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
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
1: No Intervention Pterygium free participants
2: Experimental 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:

Pterygium at least 1.5mm in extent
Both male and female
Age range 21-65 years
Consenting to participate in study
Unilateral and bilateral pterygium
All grades of pterygium

Exclusion Criteria:

Previous cataract, corneoscleral and glaucoma surgery or corneoscleral trauma and corneolimbal scars
Pseudopterygium or signs of malignancy on pterygium
Recurrent pterygium
Sufferers of collagen vascular disease, scleritis or diabetes -

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00713180

Contacts

Contact: Peter Anguria, MMed

+27765396392

irarak58@gmail.com

Locations

South Africa, Limpopo
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

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

Study placed in the following topic categories:

Eye Diseases
Pterygium of the conjunctiva
Pterygium
Conjunctival Diseases
Recurrence

ClinicalTrials.gov processed this record on January 14, 2009