Trichiasis Clinical Trial
Official title:
Trial of Antibiotics to Reduce Recurrent Trichiasis (STAR)
Trachoma, an ocular infection caused by C. trachomatis, is the second leading cause of blindness worldwide.Years of repeated infection with C. trachomatis cause the eyelid to scar and contract and ultimately to rotate inward such that eyelashes rub against the eyeball and abrade the cornea (trichiasis). The World Health Organization (WHO) has endorsed a multi-faceted strategy to combat trachoma, which includes surgery to correct trichiasis. Despite this encouraging news, under the best of circumstances the recurrence rate of trichiasis following surgery is disappointingly high. The objective of our project is to conduct a randomized, controlled clinical trial of post-surgical antibiotic treatment, comparing oral azithromycin to topical tetracycline, for trichiasis surgical patients in Ethiopia with the goal of determining the impact of treatment on rates of trichiasis recurrence at one and two years.
A randomized clinical trial of the effectiveness of a single dose of azithromycin compared
to 6 weeks of topical tetracycline, and the added benefit of family-based azithromycin
treatment, in preventing recurrence of trichiasis following surgery is proposed. This will
provide the evidence base to inform and change the global public health policy and the
donation program policy, regarding post-surgical treatment for trichiasis patients and
possibly their families.
The investigators will determine the impact of three treatment strategies following
trichiasis surgery on the rate of trichiasis recurrence in the operated eye at six months
and one year. A randomized clinical trial of 1425 trichiasis surgical patients will be
conducted in Sodo,Ethiopia. The first group (Control Group) will receive topical
tetracycline following surgery; the second group (Intervention Patient Group) will receive
oral azithromycin; the third group (Intervention Family Group) will receive oral
azithromycin, and all family members resident in the patient's household will also receive
oral azithromycin. Data will be collected at baseline (pre-surgery) on ocular status and
infection status. Data will be collected at the time of surgery on surgery-related variables
and surgical and post-operative complications. Additional data will be collected on any
surgical complications and early recurrence at the two-week visit when sutures will be
removed. A follow up visit at two months will include data collection on recurrence and
presence of ocular infection. Evaluations for trichiasis recurrence will occur again at six
months and at one year post-surgery. The latter visit will also include data collection on
presence of ocular infection in the surgical case, and ocular infection in household
members. Evaluation of the risk of recurrence at six months and one, two, and three years
within each group will be completed to determine the benefit of using azithromycin compared
to topical tetracycline, and the added benefit of family-based treatment.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
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