Three-year outcomes of the surgery for trichiasis, antibiotics to prevent recurrence trial

Abstract

Objective: To determine whether treatment with oral azithromycin compared with topical tetracycline reduces the recurrence of trichiasis for up to 3 years following surgery for trichiasis.

Methods: The Surgery for Trichiasis, Antibiotics to Prevent Recurrence (STAR) trial is a randomized, single-masked, clinical trial conducted in southern Ethiopia, a region where trachoma is hyperendemic. A total of 1452 patients who underwent trichiasis surgery were randomly assigned at a 2:1 ratio to either a single dose of oral azithromycin (1 g) or topical tetracycline (twice per day for 6 weeks) following surgery.

Main outcome measures: Recurrence of trichiasis within 3 years following surgery.

Results: The rate of recurrence was 10% in the azithromycin group and 13% in the tetracycline group. The azithromycin group had a 22% reduction in recurrence of trichiasis 3 years after surgery compared with the tetracycline group (P = .13). Severity of entropion at baseline was the most significant predictor of recurrence of trichiasis at 3 years.

Conclusion: Trichiasis recurrence rates in the STAR trial remained low for up to 3 years following surgery. The protective effect of a single dose of azithromycin was less than at 1 year and, although not statistically significant, was still suggestive up to 3 years following trichiasis surgery.

Application to clinical practice: A single dose of azithromycin after surgery remains an integral component of the World Health Organization's strategy for the elimination of trachoma by the year 2020.

Trial registration: ClinicalTrials.gov NCT00347776.

Figures

Figure 1

Flowchart of participants enrolled in the Surgery for Trichiasis, Antibiotics to Prevent Recurrence trial, at baseline and 3-year follow-up.

Figure 2

Cumulative incidence of recurrence of trichiasis by treatment group (P = .11, determined by use of the log-rank test).