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

April 21, 2009
October 20, 2011
May 2009
November 2011   (final data collection date for primary outcome measure)
Presence of trichiasis, pyogenic granuloma or lid contour abnormality post trichiasis surgery [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00886015 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Modified Instrumentation for Surgery to Correct Trichiasis
PRET Clinical Trial of Evaluation of Modified Instrumentation for Surgery to Correct Trichiasis

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).

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Trachoma
  • Device: TT Clamp
    trichiasis surgery performed with TT clamp
  • Procedure: Standard BTRP Technique
    bilamellar tarsal rotation procedure in trichiasis surgery
  • Experimental: TT Clamp
    The TT clamp will be used in trichiasis surgery.
    Intervention: Device: TT Clamp
  • Active Comparator: Standard BTRP Technique
    Standard BTRP technique will be used in trichiasis surgery.
    Intervention: Procedure: Standard BTRP Technique
Gower EW, West SK, Harding JC, Cassard SD, Munoz BE, Othman MS, Kello AB, Merbs SL. Trachomatous trichiasis clamp vs standard bilamellar tarsal rotation instrumentation for trichiasis surgery: results of a randomized clinical trial. JAMA Ophthalmol. 2013 Mar;131(3):294-301. doi: 10.1001/jamaophthalmol.2013.910.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1876
December 2011
November 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00886015
NA_00019216
Yes
Emily Gower, Johns Hopkins University
Johns Hopkins University
Bill and Melinda Gates Foundation
Principal Investigator: Emily Gower, PhD Johns Hopkins University
Johns Hopkins University
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP