Determinants of Pterygium Occurrence and Recurrence in a Rural African Population

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.

Study Overview

• Status: Completed
• Conditions: Pterygium
• Intervention / Treatment: Procedure: Pterygium excision followed by grafting

• Study Type: Interventional
• Enrollment (Anticipated): 355
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Africa
  • Limpopo
    • Polokwane, Limpopo, South Africa, 0727
      • Mankweng Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 1; Pterygium free participants
Experimental: 2; 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Anguria, Peter, M.D.
• Investigators: Principal Investigator: Peter Anguria, MMed, Mankweng Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: July 9, 2008
• First Submitted That Met QC Criteria: July 10, 2008
• First Posted (Estimate): July 11, 2008

Study Record Updates

• Last Update Posted (Estimate): June 25, 2015
• Last Update Submitted That Met QC Criteria: June 24, 2015
• Last Verified: August 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Disease Attributes; Conjunctival Diseases; Recurrence; Pterygium
• Other Study ID Numbers: Research laboratory