A Trial of Epilation Verses Surgery for Minor Trichiasis

Trachomatous Trichiasis Clinical Trial

Official title:

A Randomised Controlled Trial of Epilation Verses Immediate Surgery for the Management of Minor Trachomatous Trichiasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00522912
• Other study ID #: 5024
• Status: Completed
• Phase: N/A
• First received: August 28, 2007
• Last updated: January 11, 2012
• Start date: March 2008
• Est. completion date: May 2010

Study information

• Verified date: January 2012
• Source: London School of Hygiene and Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics CommitteeEthiopia: Ethiopia Science and Technology CommissionUnited States: Institutional Review Board
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1300
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Trachomatous Trichiasis
• Trichiasis

Intervention

Procedure:
• Trichiasis surgery
Posterior lamella tarsal rotation
• Epilation
Epilation of lashes by another well sighted person using quality epilating forceps

Locations

Country	Name	City	State
Ethiopia	Bahir Dar Regional Health Bureau	Bahir Dar	Amhara

Sponsors (1)

Lead Sponsor	Collaborator
London School of Hygiene and Tropical Medicine

Country where clinical trial is conducted

Ethiopia, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Trichiasis		One and two years	No
Secondary	Visual acuity		One and two years	No
Secondary	Corneal opacity		One and two years	No

External Links

•   Published Results