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
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
Immediate posterior lamella tarsal rotation surgery for minor trichiasis
Procedure: Trichiasis surgery
Posterior lamella tarsal rotation
Active Comparator: B
Regular epilation by another person
Epilation of lashes by another well sighted person using quality epilating forceps
- Trichiasis [ Time Frame: One and two years ]
- Visual acuity [ Time Frame: One and two years ]
- Corneal opacity [ Time Frame: One and two years ]
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
|Bahir Dar Regional Health Bureau|
|Bahir Dar, Amhara, Ethiopia|
|Principal Investigator:||Matthew J Burton, PhD FRCOphth||London School of Hygiene and Tropical Medicine|