Surgery for Trichiasis, Antibiotics to Prevent Recurrence (STAR)

Purpose:

To determine if treating trichiasis patients with a single dose of azithromycin after surgery reduces recurrence at one year compared to 6 weeks of topical tetracycline ointment following surgery.
To determine if azithromycin treatment of household members provides additional benefit, compared to treating only the surgical patient.

Background:

Trachoma is the leading infectious cause of blindness worldwide. Studies have demonstrated that a single dose of azithromycin is effective in eliminating chlamydial infection, thereby reducing the burden of trachoma in the community. Trichiasis is the end result of repeated infection with chlamyida trachomatis and is characterized by inturned eyelashes which abrade the cornea. This mechanical abrasion can lead to corneal opacity and eventually blindness. Women are affected 4 times more often than men, and it is thought that this difference may be a result of more frequent exposure to infected children. Surgery is available to correct inturned lashes; however, recurrence following surgery is as high as 50%. We hypothesized azithromycin may be helpful in reducing trichiasis recurrence following surgery.

Description:

The STAR clinical trial was conducted in rural Ethiopia from Fall 2002 through Fall 2004. The study was carried out in the Southern Nations Nationalities and People's Republic Region (SNNPR) in the Wolayta Zone. Participants were enrolled at the time of surgery and treatment was given immediately following surgery. Household members of trichiasis patients in the household treatment arm were treated within one week of the participant's surgery. Participants were followed 2 weeks, 1.5 months, 6 months and 12 months after surgery, or until the participant had recurrence in the study eye (whichever came first). At each visit an ocular exam was performed to determine the presence of trachoma and trichiasis. Ocular swabs were taken to test for C. trachomatis at 1.5 months and 12 months.

Patient Eligibility:

To be eligible for the trial patients had to be 18 years of age or older, have at least one eye with trichiasis that had not been previously operated, not have allergy to tetracycline, not be pregnant, have no other household member enrolled in the trial, and have no plans to move out of the region within the next year.

Patient Recruitment Status:

No longer recruiting. Comments: Community Health Agents screened individuals within each village for the presence of trichiasis. Individuals with trichiasis were told about the surgical services being provided in the area and were briefly told about the clinical trial. When individuals reported for trichiasis surgery, they were told in detail about the study, and if they were interested they were screened for eligibility. Each eligible, interested individual provided written consent to be in the study.

Current Status of Study:

Completed, with results published. Comments: One year follow-up was completed in 2004.

Results:

A total of 1452 trichiasis surgery patients enrolled in the trial. At one year post-surgery, the combined azithromycin groups had significantly fewer recurrences, 6.9/100 person-years overall, compared to topical tetracycline, 10.3/100 person-years (p=0.047). Between the azithromycin groups, there was no additional reduction with also treating the household members, 8.1/100 person-years, compared to treating the surgical patients alone, 5.8/100 person-years (p=0.19).

In trachoma-endemic areas, a single dose of azithromycin reduced post-surgical trichiasis recurrence rates by 1/3 compared to topical tetracycline.

Publications

Clinical Centers

wondu.alemayehu@orbis.org

NEI Representative

dfe@nei.nih.gov

Resource Centers

Central Laboratory

tquinn@jhmi.edu

Study Chair's Office

shwest@jhmi.edu

Last Updated: 3/15/2006

U. S. Department of Health and Human Services

National Institutes of Health