A Trial of Epilation Verses Surgery for Minor Trichiasis

Study Overview
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Brief Summary
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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.

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

Conditions
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Trachomatous Trichiasis

Intervention / Treatment
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* Procedure: Trichiasis surgery
* Procedure: Epilation


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Immediate posterior lamella tarsal rotation surgery for minor trichiasis | Procedure: Trichiasis surgery<br>* Posterior lamella tarsal rotation<br>|
| Active Comparator: B<br>Regular epilation by another person | Procedure: Epilation<br>* Epilation of lashes by another well sighted person using quality epilating forceps<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trichiasis |  | One and two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity |  | One and two years | 
| Corneal opacity |  | One and two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Trachoma, Trichiasis, Surgery, Epilation, Ethiopia