Overview

This trial is active, not recruiting.

Condition trachoma
Treatments tt clamp, standard btrp technique
Phase phase 3
Sponsor Johns Hopkins University
Collaborator Bill and Melinda Gates Foundation
Start date May 2009
End date November 2011
Trial size 1876 participants
Trial identifier NCT00886015, NA_00019216

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 contract and ultimately to rotate inward such that the eyelashes rub against the eyeball and abrade the cornea (trichiasis). The World Health Organization (WHO) has endorsed a multi-faceted strategy to combat trachoma which includes surgery to repair lids distorted by trachoma (trichiasis) in imminent danger of vision loss. Current evidence suggests that long-term success rates of trichiasis surgery are less than optimal due to variation in surgical technique. Previous research by this study team has demonstrated that shorter incisions have a higher rate of trichiasis recurrence. In addition, observations by this team's oculoplastic surgeon have led to the hypothesis that granuloma formation and lid contour abnormalities may result from current surgical practices. The objective of this study is to compare outcomes of trichiasis surgeries performed with the newly developed trachomatous trichiasis (TT) clamp versus surgeries following standard technique (bilamellar tarsal rotation procedure or BTRP).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
The TT clamp will be used in trichiasis surgery.
tt clamp
trichiasis surgery performed with TT clamp
(Active Comparator)
Standard BTRP technique will be used in trichiasis surgery.
standard btrp technique
bilamellar tarsal rotation procedure in trichiasis surgery

Primary Outcomes

Measure
Presence of trichiasis, pyogenic granuloma or lid contour abnormality post trichiasis surgery
time frame: 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - 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 Criteria: - Absence of upper lid trichiasis - Prior trichiasis surgery on both eyes - Age 18 or younger - Subjects who are transiently in the area

Additional Information

Official title PRET Clinical Trial of Evaluation of Modified Instrumentation for Surgery to Correct Trichiasis
Principal investigator Emily Gower, PhD
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 described in the WHO manual, "Trichiasis Surgery for Trachoma-the Bilamellar Tarsal Rotation Procedure". These procedural departures were felt to contribute to adverse outcomes, including trichiasis recurrence, granuloma formation and lid contour abnormalities. This study team developed a new surgical tool, the TT clamp, to help improve surgical outcomes following BTRP. A randomized, single-masked clinical trial will be implemented in the Mtwara region in Tanzania. Study participants will be randomized on a 1:1 basis to surgery with the TT clamp or to surgery with standard BTR equipment. All surgeries will take place at surgical centers in Mtwara and Lindi over an 8-month period. Baseline assessment for severity of trichiasis and other predictors of surgical failure will be carried out prior to surgery. Follow-up is planned at 2 weeks (for suture removal), 6 weeks, 12 months, and 24 months post-surgery. At each follow-up visit participants will be assessed for evidence of unfavorable outcomes, including trichiasis recurrence, granuloma formation, and lid contour abnormalities. All outcomes will be assessed clinically by a trained observer who is masked to intervention status.
Trial information was received from ClinicalTrials.gov and was last updated in October 2011.
Information provided to ClinicalTrials.gov by Johns Hopkins University.