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A Trial of Epilation Verses Surgery for Minor Trichiasis
This study is ongoing, but not recruiting participants.
Study NCT00522912   Information provided by London School of Hygiene and Tropical Medicine
First Received: August 28, 2007   Last Updated: December 18, 2008   History of Changes

August 28, 2007
December 18, 2008
March 2008
May 2010   (final data collection date for primary outcome measure)
Trichiasis [ Time Frame: One and two years ]
Same as current
Complete list of historical versions of study NCT00522912 on ClinicalTrials.gov Archive Site
  • Visual acuity [ Time Frame: One and two years ]
  • Corneal opacity [ Time Frame: One and two years ]
Same as current
 
A Trial of Epilation Verses Surgery for Minor Trichiasis
A Randomised Controlled Trial of Epilation Verses Immediate Surgery for the Management of Minor Trachomatous 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.

 
 
Interventional
Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Trachomatous Trichiasis
  • Procedure: Trichiasis surgery
  • Procedure: Epilation
  • Experimental: Immediate tarsal rotation surgery for minor trichiasis
  • Active Comparator: Regular epilation by another person
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
1300
May 2010
May 2010   (final data collection date for primary outcome measure)

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).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Ethiopia
 
NCT00522912
 
5024
London School of Hygiene and Tropical Medicine
 
Principal Investigator: Matthew J Burton, PhD MRCOphth London School of Hygiene and Tropical Medicine
London School of Hygiene and Tropical Medicine
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP