Modified Instrumentation for Surgery to Correct Trichiasis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Johns Hopkins University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
Emily Gower, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00886015
First received: April 21, 2009
Last updated: October 20, 2011
Last verified: October 2011
  Purpose

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).


Condition Intervention Phase
Trachoma
Device: TT Clamp
Procedure: Standard BTRP Technique
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: PRET Clinical Trial of Evaluation of Modified Instrumentation for Surgery to Correct Trichiasis

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Presence of trichiasis, pyogenic granuloma or lid contour abnormality post trichiasis surgery [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 1876
Study Start Date: May 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TT Clamp
The TT clamp will be used in trichiasis surgery.
Device: TT Clamp
trichiasis surgery performed with TT clamp
Active Comparator: Standard BTRP Technique
Standard BTRP technique will be used in trichiasis surgery.
Procedure: Standard BTRP Technique
bilamellar tarsal rotation procedure in trichiasis surgery

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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00886015

Locations
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
Bill and Melinda Gates Foundation
Investigators
Principal Investigator: Emily Gower, PhD Johns Hopkins University
  More Information

No publications provided by Johns Hopkins University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Emily Gower, Associate Professor of Ophthalmology, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00886015     History of Changes
Other Study ID Numbers: NA_00019216
Study First Received: April 21, 2009
Last Updated: October 20, 2011
Health Authority: United States: Institutional Review Board
Tanzania: National Institute for Medical Research

Keywords provided by Johns Hopkins University:
Trachoma
trichiasis
bilamellar tarsal rotation procedure

Additional relevant MeSH terms:
Trichiasis
Trachoma
Eyelid Diseases
Eye Diseases
Conjunctivitis, Bacterial
Eye Infections, Bacterial
Bacterial Infections
Chlamydia Infections
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Eye Infections
Infection
Conjunctivitis
Conjunctival Diseases
Corneal Diseases

ClinicalTrials.gov processed this record on October 19, 2014