Clinical Trials
Journal Club
March 2013

Trachomatous Trichiasis Clamp vs Standard Bilamellar Tarsal Rotation Instrumentation for Trichiasis SurgeryResults of a Randomized Clinical Trial

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Author Affiliations

Author Affiliations: Departments of Epidemiology and Prevention and Ophthalmology, Wake Forest School of Medicine, Winston-Salem, North Carolina (Dr Gower); Dana Center for Preventive Ophthalmology (Drs Gower, West, and Cassard and Mss Harding and Munoz) and Division of Oculoplastic Surgery (Dr Merbs), Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland; Kongwa Trachoma Project Satellite Office, Mtwara, Tanzania (Mr Othman); and Light for the World, Addis Ababa, Ethiopia (Dr Kello).

JAMA Ophthalmol. 2013;131(3):294-301. doi:10.1001/jamaophthalmol.2013.910

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.

Main Outcome Measures 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.

Application to Clinical Practice 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.

Trial Registration Identifier: NCT00886015