Posterior lamellar versus bilamellar tarsal rotation surgery for trachomatous trichiasis in Ethiopia: a randomised controlled trial

摘要

Summary BackgroundEyelid 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.MethodsA 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).Findings1000 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).InterpretationPLTR surgery was superior to BLTR surgery for management of trachomatous trichiasis, and could be the preferred procedure for the programmatic management of trachomatous trichiasis.FundingThe Wellcome Trust. prs.rt("abs_end"); Introduction Trachoma, a neglected tropical disease caused by Chlamydia trachomatis , is the leading infectious cause of blindness. 1 Recurrent infection drives progressive conjunctival scarring, which turns the lid and eyelashes in towards the eye (trichiasis) resulting in pain and eventually blinding corneal opacification. About 1·2 million people are irreversibly blind from this disease and about 7·2 million have trichiasis. 1 and 2 WHO recommends the SAFE strategy for trachoma control: Surgery for trichiasis, Antibiotics, Facial cleanliness, and Environmental improvement. 3 Trichiasis surgery reduces the risk of sight loss by correcting the in-turned eyelid, thus stopping the corneal damage. Surgery involves an incision through the scarred upper eyelid, parallel to the lid margin, outward rotation, and suturing in the corrected position. 4 Due to the limited number of ophthalmologists in most trachoma-endemic countries, surgery is usually done by non-physicians with limited training, equipment, and time. 3 Given these constraints, the technique needs to be simple, safe, and quick to do, whereas at the same time giving consistently good results. Unfortunately, trichiasis frequently recurs after surgery. This outcome represents a substantial limitation in preventing sight loss from trachoma. Studies have reported trichiasis recurrence rates between 10% at 3 months and up to 60% at 3 years, with an average of around 20% at 1 year. 5 , 6 , 7 , 8 , 9 , 10 , 11 , 12 , 13 and 14 Several factors contribute to recurrent trichiasis, including preoperative disease severity, surgeon skill, and surgical procedure. 15 Among these, operation type is a major determinant of outcome and subtle variations in procedure performance probably affect results. 10 , 11 and 16 Many different surgical procedures have been used to correct trichiasis, with some evidence that bilamellar tarsal rotation (BLTR) is better than others to which it has been formally compared. 10 , 11 , 15 and 17 However, it is important to determine which is the best of these options. Research in context Evidence before this study Members of our study group recently published a systematic review of the management of trachomatous trichiasis (Burton and colleagues, 2015). When preparing this systematic review, we searched CENTRAL, Ovid MEDLINE, Embase, ISRCTN registry, ClinicalTrials.gov , and WHO ICTRP. We searched until May 7, 2015, using the search terms “trachoma” and “trichiasis”. See the review's appendix for full search methods for each database. We identified one p