Clinical trial NCT00522912: A Trial of Epilation Verses Surgery for Minor Trichiasis
Official title: A Randomised Controlled Trial of Epilation Verses Immediate Surgery for the Management of Minor Trachomatous Trichiasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trachomatous Trichiasis
Keywords: Trachoma
Trichiasis
Surgery
Epilation
Ethiopia
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
First posted: 2007-08-30
Enrollment: 1300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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).

Primary outcomes:
measure: Trichiasis
timeFrame: One and two years
Secondary outcomes:
measure: Visual acuity
timeFrame: One and two years
measure: Corneal opacity
timeFrame: One and two years
Other outcomes:
Locations:
city: Bahir Dar
country: Ethiopia
facility: Bahir Dar Regional Health Bureau
state: Amhara
Study officials:
affiliation: London School of Hygiene and Tropical Medicine
name: Matthew J Burton, PhD FRCOphth
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.