Status:
COMPLETED
Modified Instrumentation for Surgery to Correct Trichiasis
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Bill and Melinda Gates Foundation
Conditions:
Trachoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Trachoma, an ocular infection caused by C. trachomatis, is the second leading infectious cause of blindness worldwide. Years of repeated infection with C. trachomatis cause the eyelid to scar and cont...
Detailed Description
Field observations in 2005 by this study's PI and oculoplastic surgeon revealed some significant departures from current trichiasis surgery procedure (bilamellar tarsal rotation procedure or BTRP), as...
Eligibility Criteria
Inclusion
- Presence of upper lid trichiasis: defined by at least one eyelash touching the globe of the eye or evidence of epilation
- No previous report of trichiasis surgery in at least one eye with trichiasis:
- eyes with prior surgery are already at high risk due to the prior surgery, and their inclusion may decrease our ability to clearly evaluate our primary outcome
- if unilateral surgery has been performed previously, only the eye without prior history of surgery will be in the study, even if both eyes require surgery
- Age 18 or older (in order to provide consent as an adult): the vast majority of trichiasis patients are aged 18 or older
- At time of enrollment, subjects must state their intention to remain in the area for two years to facilitate study follow-up
Exclusion
- Absence of upper lid trichiasis
- Prior trichiasis surgery on both eyes
- Age 18 or younger
- Subjects who are transiently in the area
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
1927 Patients enrolled
Trial Details
Trial ID
NCT00886015
Start Date
May 1 2009
End Date
June 1 2012
Last Update
May 19 2017
Active Locations (1)
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1
Johns Hopkins University
Baltimore, Maryland, United States, 21205