title: Posterior lamellar versus bilamellar tarsal rotation surgery for trachomatous trichiasis in Ethiopia: a randomised controlled trial.
abstract: BACKGROUND
  Eyelid surgery is done to correct trachomatous trichiasis to prevent blindness. However, recurrent trichiasis is frequent. Two procedures are recommended by WHO and are in routine practice: bilamellar tarsal rotation (BLTR) and posterior lamellar tarsal rotation (PLTR). This study was done to identify which procedure gives the better results.
  
  
  METHODS
  A randomised, controlled, single masked clinical trial was done in Ethiopia. Participants had upper lid trachomatous trichiasis with one or more eyelashes touching the eye or evidence of epilation, in association with tarsal conjunctival scarring. Exclusion criteria were age less than 18 years, recurrent trichiasis after previous surgery, hypertension, and pregnancy. Participants were randomly assigned (1:1) to either BLTR or PLTR surgery, stratified by surgeon. The sequences were computer-generated by an independent statistician. Surgery was done in a community setting following WHO guidelines. Participants were examined at 6 months and 12 months by assessors masked to allocation. The primary outcome was the cumulative proportion of individuals who developed recurrent trichiasis by 12 months. Primary analyses were by modified intention to treat. The intervention effect was estimated by logistic regression, controlled for surgeon as a fixed effect in the model. The trial is registered with the Pan African Clinical Trials Registry (number PACTR201401000743135).
  
  
  RESULTS
  1000 participants with trichiasis were recruited, randomly assigned, and treated (501 in the BLTR group and 499 in the PLTR group) between Feb 13, 2014, and May 31, 2014. Eight participants were not seen at either 6 month or 12 month follow-up visits and were excluded from the analysis: three from the PLTR group and five from the BLTR group. The follow-up rate at 12 months was 98%. Cumulative recurrent trichiasis by 12 months was more frequent in the BLTR group than in the PLTR group (110/496 [22%] vs 63/496 [13%]; adjusted odds ratio [OR] 1·96 [95% CI 1·40-2·75]; p=0·0001), with a risk difference of 9·50% (95% CI 4·79-14·16).
  
  
  CONCLUSIONS
  PLTR surgery was superior to BLTR surgery for management of trachomatous trichiasis, and could be the preferred procedure for the programmatic management of trachomatous trichiasis.
  
  
  BACKGROUND
  The Wellcome Trust.
authors.affiliation: London School of Hygiene & Tropical Medicine, London, UK; The Carter Center, Addis Ababa, Ethiopia.
authors.forename: Esmael
authors.initials: E
authors.lastname: Habtamu
authors.affiliation: The Carter Center, Addis Ababa, Ethiopia.
authors.forename: Tariku
authors.initials: T
authors.lastname: Wondie
authors.affiliation: The Carter Center, Addis Ababa, Ethiopia.
authors.forename: Sintayehu
authors.initials: S
authors.lastname: Aweke
authors.affiliation: The Carter Center, Addis Ababa, Ethiopia.
authors.forename: Zerihun
authors.initials: Z
authors.lastname: Tadesse
authors.affiliation: The Carter Center, Addis Ababa, Ethiopia.
authors.forename: Mulat
authors.initials: M
authors.lastname: Zerihun
authors.affiliation: Amhara Regional Health Bureau, Bahirdar, Ethiopia.
authors.forename: Zebideru
authors.initials: Z
authors.lastname: Zewudie
authors.affiliation: Light for the World, Addis Ababa, Ethiopia.
authors.forename: Amir Bedri
authors.initials: AB
authors.lastname: Kello
authors.affiliation: London School of Hygiene & Tropical Medicine, London, UK.
authors.forename: Chrissy H
authors.initials: CH
authors.lastname: Roberts
authors.affiliation: International Trachoma Initiative, Atlanta, GA, USA.
authors.forename: Paul M
authors.initials: PM
authors.lastname: Emerson
authors.affiliation: London School of Hygiene & Tropical Medicine, London, UK.
authors.forename: Robin L
authors.initials: RL
authors.lastname: Bailey
authors.affiliation: London School of Hygiene & Tropical Medicine, London, UK.
authors.forename: David C W
authors.initials: DC
authors.lastname: Mabey
authors.affiliation: London School of Hygiene & Tropical Medicine, London, UK.
authors.forename: Saul N
authors.initials: SN
authors.lastname: Rajak
authors.affiliation: The Carter Center, Atlanta, GA, USA.
authors.forename: Kelly
authors.initials: K
authors.lastname: Callahan
authors.affiliation: London School of Hygiene & Tropical Medicine, London, UK.
authors.forename: Helen A
authors.initials: HA
authors.lastname: Weiss
authors.affiliation: London School of Hygiene & Tropical Medicine, London, UK. Electronic address: Matthew.Burton@lshtm.ac.uk.
authors.forename: Matthew J
authors.initials: MJ
authors.lastname: Burton
mesh_terms: D000328:Adult; D005002:Ethiopia; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D012008:Recurrence; D012399:Rotation; D013536:Suture Techniques; D014141:Trachoma / Q000150:complications*; D058457:Trichiasis / Q000209:etiology / Q000601:surgery*; D014792:Visual Acuity