Clinical trial NCT00886015: Modified Instrumentation for Surgery to Correct Trichiasis
Official title: Partnership for the Rapid Elimination of Trachoma (PRET) Clinical Trial of Evaluation of Modified Instrumentation for Surgery to Correct Trichiasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trachoma
Keywords: Trachoma
trichiasis
bilamellar tarsal rotation procedure
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Bill and Melinda Gates Foundation
First posted: 2009-04-22
Enrollment: 1927
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

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 BLTR.

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 BLTR 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 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

Primary outcomes:
measure: Number of Eyelids With Presence of Recurrent Trichiasis
timeFrame: 2 years
measure: Number of Eyelids With Pyogenic Granuloma
timeFrame: 2 years
measure: Number of Eyelids Experiencing an Unfavorable Outcome
timeFrame: 2 years
measure: Number of Eyelids With Normal or Mild Eyelid Contour Abnormalities vs Moderate or Severe Eyelid Contour Abnormalities
timeFrame: 2 years
Secondary outcomes:
measure: Number of Eyelids With Mild, Moderate, Severe, or no Eyelid Contour Abnormality
timeFrame: 2 years
measure: Number of Eyelids With Normal, Mild, Moderate, or Severe Trachomatous Trichiasis
timeFrame: 2 Years
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Emily Gower, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gower EW, Munoz B, Rajak S, Habtamu E, West SK, Merbs SL, Harding JC, Alemayehu W, Callahan EK, Emerson PM, Gebre T, Burton MJ. Pre-operative trichiatic eyelash pattern predicts post-operative trachomatous trichiasis. PLoS Negl Trop Dis. 2019 Oct 7;13(10):e0007637. doi: 10.1371/journal.pntd.0007637. eCollection 2019 Oct.
citation: 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.