Trachomatous trichiasis clamp vs standard bilamellar tarsal rotation instrumentation for trichiasis surgery

Results of a randomized clinical trial

Emily W. Gower, Sheila K West, Jennifer C. Harding, Sandra Cassard, Beatriz Munoz, Majid S. Othman, Amir B. Kello, Shannath L Merbs

Research output: Contribution to journalArticle

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. Main Outcome Measures: Postoperative TT, pyogenic granuloma formation, and eyelid contour abnormalities, combined and individually. Results:Atotal of 1917 participantswhohad surgery (3345 eyes) were enrolled. Rates of at least 1 unfavorable outcomewere 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.

Original languageEnglish (US)
Pages (from-to)294-301
Number of pages8
JournalJAMA Ophthalmology
Volume131
Issue number3
DOIs
StatePublished - Mar 2013

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Trichiasis
Randomized Controlled Trials
Odds Ratio
Arm
Eyelids
Granuloma
Pyogenic Granuloma
Surgical Instruments

ASJC Scopus subject areas

  • Ophthalmology

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Trachomatous trichiasis clamp vs standard bilamellar tarsal rotation instrumentation for trichiasis surgery : Results of a randomized clinical trial. / Gower, Emily W.; West, Sheila K; Harding, Jennifer C.; Cassard, Sandra; Munoz, Beatriz; Othman, Majid S.; Kello, Amir B.; Merbs, Shannath L.

In: JAMA Ophthalmology, Vol. 131, No. 3, 03.2013, p. 294-301.

Research output: Contribution to journalArticle

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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. Main Outcome Measures: Postoperative TT, pyogenic granuloma formation, and eyelid contour abnormalities, combined and individually. Results:Atotal of 1917 participantswhohad surgery (3345 eyes) were enrolled. Rates of at least 1 unfavorable outcomewere 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.",
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AU - Cassard, Sandra

AU - Munoz, Beatriz

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AU - Kello, Amir B.

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