A Trial of Epilation Verses Surgery for Minor Trichiasis

Sponsor
London School of Hygiene and Tropical Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT00522912
Collaborator
(none)
1,300
1
2
26
50

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Trichiasis surgery
  • Procedure: Epilation
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
1300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomised Controlled Trial of Epilation Verses Immediate Surgery for the Management of Minor Trachomatous Trichiasis
Study Start Date :
Mar 1, 2008
Actual Primary Completion Date :
May 1, 2010
Actual Study Completion Date :
May 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: A

Immediate posterior lamella tarsal rotation surgery for minor trichiasis

Procedure: Trichiasis surgery
Posterior lamella tarsal rotation

Active Comparator: B

Regular epilation by another person

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

Outcome Measures

Primary Outcome Measures

  1. Trichiasis [One and two years]

Secondary Outcome Measures

  1. Visual acuity [One and two years]

  2. Corneal opacity [One and two years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bahir Dar Regional Health Bureau Bahir Dar Amhara Ethiopia

Sponsors and Collaborators

  • London School of Hygiene and Tropical Medicine

Investigators

  • Principal Investigator: Matthew J Burton, PhD FRCOphth, London School of Hygiene and Tropical Medicine

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier:
NCT00522912
Other Study ID Numbers:
  • 5024
First Posted:
Aug 30, 2007
Last Update Posted:
Jan 12, 2012
Last Verified:
Jan 1, 2012
Keywords provided by London School of Hygiene and Tropical Medicine
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 12, 2012