Modified Instrumentation for Surgery to Correct Trichiasis

Trachoma Clinical Trial

Official title:

PRET Clinical Trial of Evaluation of Modified Instrumentation for Surgery to Correct Trichiasis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00886015
• Other study ID #: NA_00019216
• Status: Active, not recruiting
• Phase: Phase 3
• First received: April 21, 2009
• Last updated: October 20, 2011
• Start date: May 2009
• Est. completion date: December 2011

Study information

• Verified date: October 2011
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardTanzania: National Institute for Medical Research
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1876
• Est. completion date: December 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Trachoma
• Trichiasis

Intervention

Device:
• TT Clamp
trichiasis surgery performed with TT clamp

Procedure:
• Standard BTRP Technique
bilamellar tarsal rotation procedure in trichiasis surgery

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Bill and Melinda Gates Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of trichiasis, pyogenic granuloma or lid contour abnormality post trichiasis surgery		2 years	No