Determinants of Pterygium Occurrence and Recurrence in a Rural African Population

NCT ID: NCT00713180

Last Updated: 2015-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

355 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2012-02-29

Brief Summary

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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.

Detailed Description

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Conditions

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Pterygium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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1

Pterygium free participants

Group Type NO_INTERVENTION

No interventions assigned to this group

2

Pterygium participants

Group Type EXPERIMENTAL

Pterygium excision followed by grafting

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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 -
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Anguria, Peter, M.D.

INDIV

Sponsor Role lead

Responsible Party

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Mankweng Hospital

Principal Investigators

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Peter Anguria, MMed

Role: PRINCIPAL_INVESTIGATOR

Mankweng Hospital

Locations

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Mankweng Hospital

Polokwane, Limpopo, South Africa

Site Status

Countries

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South Africa

Other Identifiers

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Research laboratory

Identifier Type: -

Identifier Source: org_study_id

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