Determinants of Pterygium Occurrence and Recurrence in a Rural African Population

Anguria, Peter, M.D.

Status: Completed

Conditions: Pterygium

Treatments: Procedure: Pterygium excision followed by grafting

Study type: Interventional

Identifiers

NCT00713180

Research laboratory

Details and patient eligibility

About

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.

Enrollment: 355 estimated patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

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 -

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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355 participants in 2 patient groups

1

No Intervention group

Description:

Pterygium free participants

2

Experimental group

Description:

Pterygium participants

Treatment:

Procedure: Pterygium excision followed by grafting