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Completed

NCT Number: NCT00522912

A Trial of Epilation Verses Surgery for Minor Trichiasis

Trachoma is the leading infectious cause of blindness worldwide. Recurrent infection by Chlamydia trachomatis causes a gradual scarring process of the inner surface of the eyelid (conjunctiva) leading to in-turning of the eyelids (entropion) and lashes touching the eye (trichiasis). The rate of progression and the severity of disease are variable. Some people develop severe disease with extensive entropion and trichiasis, whilst others have a mild problem with only a few lashes touching the eye, which does not progress.

In more advanced cases there is a broad consensus that the entropion / trichiasis should be corrected by surgery. In mild cases (minor trichiasis: 1-5 lashes touching the eye) the optimal treatment is uncertain. Some advocate early surgery to turn the eyelid out for any individual with one or more lashes touching any part of the eye. Others consider this to be too early for surgical intervention, as surgery can have a high recurrence rate and complications can arise. Instead, they recommend that minor trichiasis can be managed by epilation (pulling out lashes with forceps). In many endemic regions the uptake of surgery is low, with many patients preferring to epilate for mild disease.

The primary purpose of this study is to compare the outcome of immediate surgery to regular epilation for the management of minor trichiasis. The epilation would be done by a person with good eyesight using proper epilation forceps.

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Key information

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Minor trichiasis: 1 - 5 lashes touching the eye

Exclusion criteria

  • Previous eyelid surgery.
  • Patients with evidence of corneal damage (will be offered surgery).

Treatment and study plan

Trichiasis surgery

Procedure

Posterior lamella tarsal rotation

Epilation

Procedure

Epilation of lashes by another well sighted person using quality epilating forceps

Primary outcomes

  1. Trichiasis

    Time frame: One and two years

Secondary outcomes

  1. Visual acuity

    Time frame: One and two years

  2. Corneal opacity

    Time frame: One and two years

Sponsors and collaborators

Lead sponsor

London School of Hygiene and Tropical Medicine

Other

Registry information

Official study title

A Randomised Controlled Trial of Epilation Verses Immediate Surgery for the Management of Minor Trachomatous Trichiasis

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Aug 30, 2007
Registry last updated
Jan 12, 2012

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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