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Trachomatous Trichiasis Clamp vs Standard Bilamellar Tarsal Rotation Instrumentation for Trichiasis Surgery: Results of a Randomized Clinical Trial.
MedLine Citation:
PMID:  23143400     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
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 clinicaltrials.gov Identifier: NCT00886015.
Authors:
Emily W Gower; Sheila K West; Jennifer C Harding; Sandra D Cassard; Beatriz E Munoz; Majid S Othman; Amir B Kello; Shannath L Merbs
Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-11-9
Journal Detail:
Title:  Archives of ophthalmology     Volume:  -     ISSN:  1538-3601     ISO Abbreviation:  Arch. Ophthalmol.     Publication Date:  2012 Nov 
Date Detail:
Created Date:  2012-11-12     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  7706534     Medline TA:  Arch Ophthalmol     Country:  -    
Other Details:
Languages:  ENG     Pagination:  1-8     Citation Subset:  -    
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