Trachomatous TrichiasisNCT00522912
A Trial of Epilation Verses Surgery for Minor Trichiasis
A study testing Trichiasis surgery and Epilation in people with Trachomatous Trichiasis, run by London School of Hygiene and Tropical Medicine at 1 site in Ethiopia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trachomatous Trichiasis
- What is being tested?
- Trichiasis surgery and Epilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,300 participants
- Where
- 1 siteEthiopia
- Study dates
- Mar 2008to May 2010
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Minor trichiasis: 1 - 5 lashes touching the eye
Who cannot join
- Previous eyelid surgery.
- Patients with evidence of corneal damage (will be offered surgery).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Controlled Trial of Epilation Verses Immediate Surgery for the Management of Minor Trachomatous Trichiasis
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.
- Conditions
- Trachomatous Trichiasis
- Being tested
- Trichiasis surgery, Epilation
- Keywords
- Trachoma, Trichiasis, Surgery, Epilation, Ethiopia
- Medical subject headings
- Trachoma, Trichiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trichiasis surgeryProcedure or surgery
Posterior lamella tarsal rotation
EpilationProcedure or surgery
Epilation of lashes by another well sighted person using quality epilating forceps
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Immediate posterior lamella tarsal rotation surgery for minor trichiasis Receives: Procedure: Trichiasis surgery |
| B | Active comparator | Regular epilation by another person Receives: Procedure: Epilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trichiasis
Measured: One and two years
Secondary outcomes (2)
Visual acuity
Measured: One and two years
Corneal opacity
Measured: One and two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2007 (estimated)
- Study startMar 2008
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Trachomatous TrichiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,300 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew J Burton, PhD FRCOphth, Principal investigator, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00522912
- Sponsor's protocol ID
- 5024
- Status last verified
- Jan 2012
- First submitted
- 28 Aug 2007
- Last updated
- 12 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22180731Gower 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.
PubMed 31589610Rajak 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.
PubMed 22953007