jama ophthalmology journal club slides: tt clamp vs standard bltr for trichiasis surgery
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JAMA Ophthalmology Journal Club Slides: TT Clamp vs Standard BLTR for Trichiasis Surgery. - PowerPoint PPT PresentationTRANSCRIPT
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JAMA Ophthalmology Journal Club Slides:TT Clamp vs Standard BLTR
for Trichiasis Surgery
Gower EW, West SK, Harding JC, et al. Trachomatous trichiasis clamp vs standard bilamellar tarsal rotation instrumentation for trichiasis surgery. JAMA Ophthalmol. Published online November 9, 2012. doi:10.1001/jamaophthalmol.2013.910.
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Introduction
• Trachomatous trichiasis (TT) is the leading infectious cause of blindness. It is the result of years of ocular chlamydial infection, which causes the eyelid to scar and turn inward such that eyelashes abrade the eye.
• Corrective surgery is performed by surgical technicians with limited training.
• Postoperative trichiasis is common.
• Previous research shows that surgical factors likely play a role in postoperative TT and other unfavorable outcomes.
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Objective
• To determine whether a newly designed surgical tool, the TT clamp, could reduce the rate of unfavorable outcomes occurring within 2 years following surgery.
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• Study Design:
– Prospective, randomized, single-masked clinical trial.
– 18 surgeons were randomized to perform surgery with the TT clamp or standard bilamellar tarsal rotation (BLTR) instrumentation.
– Patients were randomized to surgery with standard BLTR instrumentation or the TT clamp and were followed up for 2 years postoperatively.
• Participants: Patients undergoing trichiasis surgery in southern Tanzania.
Methods
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Methods
• Data Analysis:
– 3 outcomes were evaluated individually and combined.
– Outcomes included postoperative trichiasis, pyogenic granuloma formation, and eyelid contour abnormality.
– Generalized linear mixed models were used to evaluate the relative risk of events between the TT clamp and standard BLTR.
• Limitations:
– Each surgical technician performed only 1 type of surgery. An attempt was made to match technicians based on surgical skill, but differences between groups may have existed.
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• 1917 individuals were randomized: 957 to TT clamp, 960 to standard BLTR.
• 74.4% were female.
• Eyes undergoing surgery: 1671 with TT clamp, 1674 with standard BLTR.
• 23.9% of patients were blind in at least 1 eye.
• Baseline characteristics were comparable between groups except TT severity. The TT clamp group had more severe baseline trichiasis (a risk factor for recurrence).
Results
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Characteristics of Study Eyes at Last Visita
Results
Overall rates of at least 1 unfavorable outcome were similar between groups and higher than is desirable.
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Results
After adjustment, no differences were seen in the rate of at least 1 unfavorable outcome. Granulomas and moderate to severe eyelid contour abnormalities were less likely in the TT clamp group, while postoperative TT was somewhat more common.
Outcomes in the TT Clamp Group vs the Standard BLTR Group
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• Overall rates of at least 1 unfavorable outcome were similar between groups, but types of outcomes differed between groups.
• Granuloma and eyelid contour abnormalities were more common using standard BLTR. These findings are consistent with our initial hypothesis: use of the TT clamp will ensure a single full-thickness incision with less risk of jagged tissue fragments and beveled incisions, 2 factors believed to be important for these outcomes.
• Postoperative TT was more common in the TT clamp group. Baseline TT severity is a predictor of postoperative TT. The approach for suturing with the TT clamp may have had an effect on the risk of postoperative TT. This area needs to be investigated further.
Comment
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• If you have questions, please contact the corresponding author:– Emily W. Gower, PhD, Departments of Epidemiology and Prevention and
Ophthalmology, Wake Forest School of Medicine, Wake Forest Health Sciences, Medical Center Boulevard, Winston-Salem, NC 27157 ([email protected]).
Conflict of Interest Disclosures• None reported.
Funding/Support• This work was supported by a grant from the Bill and Melinda Gates Foundation.
Helen Keller International provided manpower and funding to assist in screening and surgery. Beaver-Visitec International Inc provided manpower and materials to produce the TT clamp at no charge. Drs Gower and West are recipients of awards from Research to Prevent Blindness.
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