NCT00522912|CompletedDMC
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
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A Randomised Controlled Trial of Epilation Verses Immediate Surgery for the Management of Minor Trachomatous Trichiasis
Sponsor study identifier
interventional
1,300
1 country
1
Study Start
March 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2010
Actual (reported)Study Completion
May 2010
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2010
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 28, 2007
Actual (reported)August 30, 2007
Actual (reported)March 2008
Date type not reportedThis date has not been verified as actual or estimated.
May 2010
Actual (reported)May 2010
Actual (reported)Trichiasis
One and two years
Visual acuity
One and two years
Corneal opacity
One and two years
Immediate posterior lamella tarsal rotation surgery for minor trichiasis
Regular epilation by another person
Posterior lamella tarsal rotation
Epilation of lashes by another well sighted person using quality epilating forceps
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Bahir Dar Regional Health Bureau
Bahir Dar, Amhara, Ethiopia
Rajak SN, Habtamu E, Weiss HA, Kello AB, Gebre T, Genet A, Bailey RL, Mabey DC, Khaw PT, Gilbert CE, Emerson PM, Burton MJ. Surgery versus epilation for the treatment of minor trichiasis in Ethiopia: a randomised controlled noninferiority trial. PLoS Med. 2011 Dec;8(12):e1001136. doi: 10.1371/journal.pmed.1001136. Epub 2011 Dec 13.
Gower EW, Munoz B, Rajak S, Habtamu E, West SK, Merbs SL, Harding JC, Alemayehu W, Callahan EK, Emerson PM, Gebre T, Burton MJ. Pre-operative trichiatic eyelash pattern predicts post-operative trachomatous trichiasis. PLoS Negl Trop Dis. 2019 Oct 7;13(10):e0007637. doi: 10.1371/journal.pntd.0007637. eCollection 2019 Oct.
Matthew J Burton, PhD FRCOphth
London School of Hygiene and Tropical Medicine
1,300 participants (actual enrollment reported by the registry).
First Submitted
August 28, 2007
First Posted
August 30, 2007
Study Start
March 2008
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Rajak SN, Habtamu E, Weiss HA, Bedri A, Zerihun M, Gebre T, Gilbert CE, Emerson PM, Burton MJ. Why do people not attend for treatment for trachomatous trichiasis in Ethiopia? A study of barriers to surgery. PLoS Negl Trop Dis. 2012;6(8):e1766. doi: 10.1371/journal.pntd.0001766. Epub 2012 Aug 28.
Primary Completion
May 2010
Actual (reported)Study Completion
May 2010
Actual (reported)Last Updated
January 12, 2012
Record last verified: 2012-01
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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