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Fasika A. Woreta, Beatriz Munoz, Emily S. West, Wondu Alemayehu, Sheila K. West; Three Year Outcomes of the Surgery for Trichiasis, Antibiotics to Prevent Recurrence (STAR) Trial. Invest. Ophthalmol. Vis. Sci. 2011;52(14):5912.
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To determine whether post-surgical treatment with oral azithromycin compared to topical tetracycline reduces trichiasis recurrence up to three years following trichiais surgery.
The study uses data from the Surgery for Trichiasis, Antibiotics to Prevent Recurrence (STAR) trial, a randomized, single masked clinical trial of 1452 patients who underwent trichiasis surgery in the Wolyayta Soddo Zone of southern Ethiopia, a region where trachoma is hyperendemic. Patients aged 18 years or older with trichiasis in at least one eye not previously treated surgically were eligible for the trial. All patients underwent bilamellar tarsal rotation performed by local integrated eye care workers. The participants were randomized 2:1 to receive either a single one-gram dose of azithromycin or topical tetracycline twice daily for six weeks. Throughout the trial, patients were examined for trichiasis recurrence and severity of recurrence at 2, 6, 12, 18, 24 and 36 months. Survival analysis methodology was used to estimate the cumulative recurrence to three years by randomization group.
Baseline characteristics of the 1452 patients were similar across groups. At baseline, 47% in the tetracycline group and 42.9% in the azithromycin group had moderate or severe entropion. Analysis of the STAR data at one year showed that the azithromycin group had significantly fewer trichiasis recurrences when compared with the tetracycline group (8% versus 11%, p=0.04). Three years after surgery, the recurrence rate was still low. The azithromycin treatment group had an 11% recurrence rate versus 14% in those treated with topical tetracycline, although this difference was not statistically significant (p=0.11). Baseline severity of entropion was the most significant predictor of trichiasis recurrence at three years (hazard ratio, 1.76; 95% CI, 1.21-2.15 for moderate entropion and 3.05, 95% CI, 2.05-4.51 for severe entropion).
Overall recurrence rates in this trial continue to be very low at three years, below those reported from other trials and programs. The protective effect of azithromycin was still evident, but not significant at three years.
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