title: Trachomatous trichiasis clamp vs standard bilamellar tarsal rotation instrumentation for trichiasis surgery: results of a randomized clinical trial.
abstract: OBJECTIVE
  To determine whether a new surgical clamp reduces unfavorable postoperative outcomes.
  
  
  METHODS
  Patients with trachomatous trichiasis (TT) were randomized to surgery with standard bilamellar tarsal rotation (BLTR) instrumentation or the TT clamp and were followed up for 2 years.
  
  
  METHODS
  Postoperative TT, pyogenic granuloma formation, and eyelid contour abnormalities, combined and individually.
  
  
  RESULTS
  A total of 1917 participants who had surgery (3345 eyes) were enrolled. Rates of at least 1 unfavorable outcome were similar for the participants who underwent surgery with the TT clamp and those who underwent surgery with standard BLTR (60.9% vs 63.0%, respectively; adjusted odds ratio [AOR] = 0.88; 95% CI, 0.66-1.18). Granuloma was less common in the TT clamp arm than in the standard BLTR arm (16.8% vs 22.4%, respectively; AOR = 0.67; 95% CI, 0.46-0.97). There was a trend toward increased postoperative TT in the TT clamp arm compared with the standard BLTR arm (43.2% vs 36.6%, respectively; AOR = 1.36; 95% CI, 0.96-1.93). The TT clamp decreased the risk of mild eyelid contour abnormalities compared with standard BLTR (9.1% vs 13.3%, respectively; AOR = 0.64; 95% CI, 0.42-0.97) and showed a trend for a decrease in moderate abnormalities (5.3% vs 7.8%, respectively; AOR = 0.63; 95% CI, 0.39-1.01).
  
  
  CONCLUSIONS
  Overall, rates of unfavorable outcomes were similar between groups. Although our results are similar to other programmatic settings, such high rates of unfavorable outcomes are unacceptable; future research is needed to identify ways to improve TT surgery outcomes.
  
  
  CONCLUSIONS
  A new clamp for TT surgery appears to offer protection against granuloma formation and some eyelid contour abnormalities, but it does not reduce postoperative TT.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT00886015.
authors.affiliation: Departments of Epidemiology and Prevention and Ophthalmology, Wake Forest School of Medicine, Winston-Salem, NC 27157, USA. egower@wakehealth.edu
authors.forename: Emily W
authors.initials: EW
authors.lastname: Gower
authors.forename: Sheila K
authors.initials: SK
authors.lastname: West
authors.forename: Jennifer C
authors.initials: JC
authors.lastname: Harding
authors.forename: Sandra D
authors.initials: SD
authors.lastname: Cassard
authors.forename: Beatriz E
authors.initials: BE
authors.lastname: Munoz
authors.forename: Majid S
authors.initials: MS
authors.lastname: Othman
authors.forename: Amir B
authors.initials: AB
authors.lastname: Kello
authors.forename: Shannath L
authors.initials: SL
authors.lastname: Merbs
mesh_terms: D000328:Adult; D004311:Double-Blind Method; D004483:Ectropion / Q000601:surgery; D005140:Eyelashes; D005141:Eyelid Diseases / Q000209:etiology; D005143:Eyelids / Q000601:surgery*; D005260:Female; D017789:Granuloma, Pyogenic / Q000209:etiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D013508:Ophthalmologic Surgical Procedures / Q000295:instrumentation*; D011183:Postoperative Complications; D013525:Surgical Instruments; D013536:Suture Techniques; D014141:Trachoma / Q000209:etiology / Q000601:surgery*; D016896:Treatment Outcome; D058457:Trichiasis / Q000209:etiology / Q000601:surgery*; D014792:Visual Acuity