CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,927 enrolled
Drug / intervention
TT Clamp +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00886015
NCT00886015N/ACompleted

Partnership for the Rapid Elimination of Trachoma (PRET) Clinical Trial of Evaluation of Modified Instrumentation for Surgery to Correct Trichiasis

Johns Hopkins University·interventional·Posted Apr 22, 2009·Updated May 19, 2017

In Brief

A clinical study evaluating TT Clamp and Standard BLTR Technique for Trachoma. Completed, enrolled 1,927 participants across 1 site.

Detailed 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 BLTR).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTrachoma
CountriesUnited States

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 22, 2009
Enrollment StartMay 1, 2009
Primary CompletionJan 1, 2012
Study CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 17.2 years ago

Interventions

TT Clampdevice

trichiasis surgery performed with TT clamp

Standard BLTR Techniqueprocedure

bilamellar tarsal rotation procedure in trichiasis surgery