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Sponsored by: |
London School of Hygiene and Tropical Medicine |
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Information provided by: | London School of Hygiene and Tropical Medicine |
ClinicalTrials.gov Identifier: | NCT00522912 |
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 |
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Trachomatous Trichiasis |
Procedure: Trichiasis surgery Procedure: Epilation |
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 |
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 |
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A: Experimental
Immediate tarsal rotation surgery for minor trichiasis
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Procedure: Trichiasis surgery |
B: Active Comparator
Regular epilation by another person
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Procedure: Epilation
Epilation of lashes by another well sighted person using quality epilating forceps
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Ethiopia, Amhara | |
Bahir Dar Regional Health Bureau | |
Bahir Dar, Amhara, Ethiopia |
Principal Investigator: | Matthew J Burton, PhD MRCOphth | London School of Hygiene and Tropical Medicine |
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 |
Trachoma Trichiasis Surgery Epilation Ethiopia |
Trachoma |