A Trial of Epilation Verses Surgery for Minor Trichiasis

Not Applicable

Completed

• Conditions: Trachomatous Trichiasis
• Interventions: Procedure: Trichiasis surgery; Procedure: Epilation

• Registration Number: NCT00522912
• Lead Sponsor: London School of Hygiene and Tropical Medicine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-08-28
• Study First Submitted QC: 2007-08-28
• Study First Posted: 2007-08-30
• Study Start: 2008-03
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-11
• Last Update Posted: 2012-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1300

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Trichiasis surgery	Immediate posterior lamella tarsal rotation surgery for minor trichiasis
B	Epilation	Regular epilation by another person

Primary Outcome Measures

Name	Time	Method
Trichiasis	One and two years

Secondary Outcome Measures

Name	Time	Method
Visual acuity	One and two years
Corneal opacity	One and two years

Trial Locations

Locations (1)

Bahir Dar Regional Health Bureau; 🇪🇹 Bahir Dar, Amhara, Ethiopia