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A Trial of Epilation Verses Surgery for Minor Trichiasis
This study is ongoing, but not recruiting participants.
Sponsored by: London School of Hygiene and Tropical Medicine
Information provided by: London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT00522912
  Purpose

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.


Condition Intervention
Trachomatous Trichiasis
Procedure: Trichiasis surgery
Procedure: Epilation

U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title: A Randomised Controlled Trial of Epilation Verses Immediate Surgery for the Management of Minor Trachomatous Trichiasis

Further study details as provided by London School of Hygiene and Tropical Medicine:

Primary Outcome Measures:
  • Trichiasis [ Time Frame: One and two years ]

Secondary Outcome Measures:
  • Visual acuity [ Time Frame: One and two years ]
  • Corneal opacity [ Time Frame: One and two years ]

Estimated Enrollment: 1300
Study Start Date: March 2008
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Experimental
Immediate tarsal rotation surgery for minor trichiasis
Procedure: Trichiasis surgery
B: Active Comparator
Regular epilation by another person
Procedure: Epilation
Epilation of lashes by another well sighted person using quality epilating forceps

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00522912

Locations
Ethiopia, Amhara
Bahir Dar Regional Health Bureau
Bahir Dar, Amhara, Ethiopia
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
Investigators
Principal Investigator: Matthew J Burton, PhD MRCOphth London School of Hygiene and Tropical Medicine
  More Information

Study ID Numbers: 5024
Study First Received: August 28, 2007
Last Updated: December 18, 2008
ClinicalTrials.gov Identifier: NCT00522912  
Health Authority: United Kingdom: Research Ethics Committee;   Ethiopia: Ethiopia Science and Technology Commission;   United States: Institutional Review Board

Keywords provided by London School of Hygiene and Tropical Medicine:
Trachoma
Trichiasis
Surgery
Epilation
Ethiopia

Study placed in the following topic categories:
Trachoma

ClinicalTrials.gov processed this record on January 16, 2009