NCT00522912

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 30, 2007

Completed
6 months until next milestone

Study Start

First participant enrolled

March 1, 2008

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

January 12, 2012

Status Verified

January 1, 2012

Enrollment Period

2.2 years

First QC Date

August 28, 2007

Last Update Submit

January 11, 2012

Conditions

Trachomatous Trichiasis

Keywords

TrachomaTrichiasisSurgeryEpilationEthiopia

Outcome Measures

Primary Outcomes (1)

  • Trichiasis

    One and two years

Secondary Outcomes (2)

  • Visual acuity

    One and two years

  • Corneal opacity

    One and two years

Study Arms (2)

A

EXPERIMENTAL

Immediate posterior lamella tarsal rotation surgery for minor trichiasis

Procedure: Trichiasis surgery

B

ACTIVE COMPARATOR

Regular epilation by another person

Procedure: Epilation

Interventions

Trichiasis surgeryPROCEDURE

Posterior lamella tarsal rotation

A
EpilationPROCEDURE

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

B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Minor trichiasis: 1 - 5 lashes touching the eye

You may not qualify if:

  • Previous eyelid surgery.
  • Patients with evidence of corneal damage (will be offered surgery).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bahir Dar Regional Health Bureau

Bahir Dar, Amhara, Ethiopia

Location

Related Publications (3)

  • 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.

    PMID: 22180731RESULT

  • 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.

    PMID: 31589610DERIVED

  • 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.

    PMID: 22953007DERIVED

Related Links

MeSH Terms

Conditions

TrachomaTrichiasis

Interventions

Hair Removal

Condition Hierarchy (Ancestors)

Conjunctivitis, BacterialEye Infections, BacterialBacterial InfectionsBacterial Infections and MycosesInfectionsChlamydia InfectionsChlamydiaceae InfectionsGram-Negative Bacterial InfectionsEye InfectionsConjunctivitisConjunctival DiseasesEye DiseasesCorneal DiseasesEyelid Diseases

Intervention Hierarchy (Ancestors)

Cosmetic TechniquesTherapeutics

Study Officials

  • Matthew J Burton, PhD FRCOphth

    London School of Hygiene and Tropical Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2007

First Posted

August 30, 2007

Study Start

March 1, 2008

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

January 12, 2012

Record last verified: 2012-01

Locations

ET(1)