Determinants of Pterygium Occurrence and Recurrence in a Rural African Population

Pterygium Clinical Trial

Official title:

Determinants of Pterygium Occurrence and Recurrence in a Rural African Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00713180
• Other study ID #: Research laboratory
• Status: Completed
• Phase: N/A
• First received: July 9, 2008
• Last updated: June 24, 2015
• Start date: August 2008
• Est. completion date: February 2012

Study information

• Verified date: August 2008
• Source: Anguria, Peter, M.D.
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: National Health Research Ethics Council
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 355
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

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 -

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pterygium

Intervention

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

Locations

Country	Name	City	State
South Africa	Mankweng Hospital	Polokwane	Limpopo

Sponsors (1)

Lead Sponsor	Collaborator
Anguria, Peter, M.D.

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	None recurrence of pterygium		6 months of follow up after operation	No
Secondary	corneal scarring		6 months of follow up	Yes
Secondary	tenon's granuloma		6 months of follow up	Yes
Secondary	graft retraction		one month of follow up	Yes
Secondary	Graft haematoma		one week of follow up	Yes
Secondary	Graft hyperaemia		3 months of follow up	Yes