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A Trial of Epilation Verses Surgery for Minor Trichiasis

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ClinicalTrials.gov Identifier: NCT00522912
Recruitment Status : Completed
First Posted : August 30, 2007
Last Update Posted : January 12, 2012
Sponsor:
Information provided by (Responsible Party):
London School of Hygiene and Tropical Medicine

Brief Summary:

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 or disease Intervention/treatment Phase
Trachomatous Trichiasis Procedure: Trichiasis surgery Procedure: Epilation Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised Controlled Trial of Epilation Verses Immediate Surgery for the Management of Minor Trachomatous Trichiasis
Study Start Date : March 2008
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: A
Immediate posterior lamella tarsal rotation surgery for minor trichiasis
Procedure: Trichiasis surgery
Posterior lamella tarsal rotation
Active Comparator: B
Regular epilation by another person
Procedure: Epilation
Epilation of lashes by another well sighted person using quality epilating forceps



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

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


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00522912


Locations
Ethiopia
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 FRCOphth London School of Hygiene and Tropical Medicine

Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT00522912     History of Changes
Other Study ID Numbers: 5024
First Posted: August 30, 2007    Key Record Dates
Last Update Posted: January 12, 2012
Last Verified: January 2012

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

Additional relevant MeSH terms:
Trichiasis
Eyelid Diseases
Eye Diseases