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A Trial of Epilation Verses Surgery for Minor Trichiasis

Primary Purpose

Trachomatous Trichiasis

Status
Completed
Phase
Not Applicable
Locations
Ethiopia
Study Type
Interventional
Intervention
Trichiasis surgery
Epilation
Sponsored by
London School of Hygiene and Tropical Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trachomatous Trichiasis focused on measuring Trachoma, Trichiasis, Surgery, Epilation, Ethiopia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Bahir Dar Regional Health Bureau

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A

B

Arm Description

Immediate posterior lamella tarsal rotation surgery for minor trichiasis

Regular epilation by another person

Outcomes

Primary Outcome Measures

Trichiasis

Secondary Outcome Measures

Visual acuity
Corneal opacity

Full Information

First Posted
August 28, 2007
Last Updated
January 11, 2012
Sponsor
London School of Hygiene and Tropical Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00522912
Brief Title
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

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
London School of Hygiene and Tropical Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trachomatous Trichiasis
Keywords
Trachoma, Trichiasis, Surgery, Epilation, Ethiopia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Immediate posterior lamella tarsal rotation surgery for minor trichiasis
Arm Title
B
Arm Type
Active Comparator
Arm Description
Regular epilation by another person
Intervention Type
Procedure
Intervention Name(s)
Trichiasis surgery
Intervention Description
Posterior lamella tarsal rotation
Intervention Type
Procedure
Intervention Name(s)
Epilation
Intervention Description
Epilation of lashes by another well sighted person using quality epilating forceps
Primary Outcome Measure Information:
Title
Trichiasis
Time Frame
One and two years
Secondary Outcome Measure Information:
Title
Visual acuity
Time Frame
One and two years
Title
Corneal opacity
Time Frame
One and two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew J Burton, PhD FRCOphth
Organizational Affiliation
London School of Hygiene and Tropical Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bahir Dar Regional Health Bureau
City
Bahir Dar
State/Province
Amhara
Country
Ethiopia

12. IPD Sharing Statement

Citations:
PubMed Identifier
22180731
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.
Results Reference
result
PubMed Identifier
31589610
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.
Results Reference
derived
PubMed Identifier
22953007
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.
Results Reference
derived
Links:
URL
http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1001136
Description
Published Results

Learn more about this trial

A Trial of Epilation Verses Surgery for Minor Trichiasis

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