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OpenTrials
Completed

NCT Number: NCT00713180

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.

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Key information

Conditions

Pterygium Conjunctival Diseases Eye Diseases

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mankweng Hospital

Polokwane, Limpopo, 0727, South Africa

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pterygium at least 1.5mm in extent
  • Both male and female
  • Age range 21-65 years
  • Consenting to participate in study
  • Unilateral and bilateral pterygium
  • All grades of pterygium

Exclusion criteria

  • Previous cataract, corneoscleral and glaucoma surgery or corneoscleral trauma and corneolimbal scars
  • Pseudopterygium or signs of malignancy on pterygium
  • Recurrent pterygium
  • Sufferers of collagen vascular disease, scleritis or diabetes -

Treatment and study plan

Pterygium excision followed by grafting

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

Primary outcomes

  1. None recurrence of pterygium

    Time frame: 6 months of follow up after operation

Secondary outcomes

  1. corneal scarring

    Time frame: 6 months of follow up

  2. tenon's granuloma

    Time frame: 6 months of follow up

  3. graft retraction

    Time frame: one month of follow up

  4. Graft haematoma

    Time frame: one week of follow up

  5. Graft hyperaemia

    Time frame: 3 months of follow up

Sponsors and collaborators

Lead sponsor

Anguria, Peter, M.D.

Indiv

Registry information

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Jul 11, 2008
Registry last updated
Jun 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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