Determinants of Pterygium Occurrence and Recurrence in a Rural African Population

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00713180

Enrollment

355

Registered

2008-07-11

Start date

2008-08-31

Completion date

2012-02-29

Last updated

2015-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pterygium

Brief summary

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.

Interventions

PROCEDUREPterygium 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

21 Years to 65 Years

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 -

Design outcomes

Primary

Measure	Time frame
None recurrence of pterygium	6 months of follow up after operation

Secondary

Measure	Time frame
corneal scarring	6 months of follow up
tenon's granuloma	6 months of follow up
graft retraction	one month of follow up
Graft haematoma	one week of follow up
Graft hyperaemia	3 months of follow up

Countries

South Africa

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026