A Trial of Epilation Verses Surgery for Minor Trichiasis

NCT ID: NCT00522912

Last Updated: 2012-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2010-05-31

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.

Detailed Description

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Conditions

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Trachomatous Trichiasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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A

Immediate posterior lamella tarsal rotation surgery for minor trichiasis

Group Type EXPERIMENTAL

Trichiasis surgery

Intervention Type PROCEDURE

Posterior lamella tarsal rotation

B

Regular epilation by another person

Group Type ACTIVE_COMPARATOR

Epilation

Intervention Type PROCEDURE

Epilation of lashes by another well sighted person using quality epilating forceps

Interventions

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Trichiasis surgery

Posterior lamella tarsal rotation

Intervention Type PROCEDURE

Epilation

Epilation of lashes by another well sighted person using quality epilating forceps

Intervention Type PROCEDURE

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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthew J Burton, PhD FRCOphth

Role: PRINCIPAL_INVESTIGATOR

London School of Hygiene and Tropical Medicine

Locations

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Bahir Dar Regional Health Bureau

Bahir Dar, Amhara, Ethiopia

Site Status

Countries

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Ethiopia

References

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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.

Reference Type RESULT
PMID: 22180731 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31589610 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22953007 (View on PubMed)

Related Links

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Other Identifiers

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5024

Identifier Type: -

Identifier Source: org_study_id

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