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A Trial of Epilation Verses Surgery for Minor Trichiasis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier:
NCT00522912
First received: August 28, 2007
Last updated: January 11, 2012
Last verified: January 2012
  Purpose

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 Intervention
Trachomatous Trichiasis
Procedure: Trichiasis surgery
Procedure: Epilation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised Controlled Trial of Epilation Verses Immediate Surgery for the Management of Minor Trachomatous Trichiasis

Resource links provided by NLM:


Further study details as provided by London School of Hygiene and Tropical Medicine:

Primary Outcome Measures:
  • Trichiasis [ Time Frame: One and two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Visual acuity [ Time Frame: One and two years ] [ Designated as safety issue: No ]
  • Corneal opacity [ Time Frame: One and two years ] [ Designated as safety issue: No ]

Enrollment: 1300
Study Start Date: March 2008
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00522912

Locations
Ethiopia
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
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT00522912     History of Changes
Other Study ID Numbers: 5024
Study First Received: August 28, 2007
Last Updated: January 11, 2012
Health Authority: United Kingdom: Research Ethics Committee
Ethiopia: Ethiopia Science and Technology Commission
United States: Institutional Review Board

Keywords provided by London School of Hygiene and Tropical Medicine:
Trachoma
Trichiasis
Surgery
Epilation
Ethiopia

Additional relevant MeSH terms:
Trichiasis
Eye Diseases
Eyelid Diseases

ClinicalTrials.gov processed this record on November 23, 2014