Bilateral Refractive Amblyopia Treatment Study (ATS7)
|ClinicalTrials.gov Identifier: NCT00305955|
Recruitment Status : Completed
First Posted : March 22, 2006
Last Update Posted : March 24, 2010
The purpose of this study will be to:
- Determine the amount of visual acuity improvement with treatment of presumed bilateral refractive amblyopia
- Determine the time course of visual acuity improvement with treatment
|Condition or disease||Intervention/treatment||Phase|
|Bilateral Refractive Amblyopia||Device: Spectacles||Phase 3|
There is a paucity of literature on bilateral amblyopia that is due to a substantial amount of refractive error (hypermetropia or astigmatism), and it is limited principally to review articles and case reports. The incidence is not known, but in one study, 4 of 830 (0.5%) children examined at the time of entry into school had bilateral amblyopia. Schoenleber et al performed a retrospective review of office records and identified 184 children with > +4.00 diopters of hypermetropia in both eyes, 12 of whom (6.5%) had bilateral amblyopia of 20/50 or worse. Ten of the 12 children (83%) improved to 20/40 or better in both eyes over a mean follow-up time of 22 months. Werner and Scott reported 6 cases of bilateral hypermetropic amblyopia with a spherical equivalent of at least +5.00 D and an initial visual acuity of 20/40 or worse in both eyes. All 5 patients with follow up improved with glasses alone, and 2 of these 5 had a most recent visual acuity worse than 20/40 in one eye with follow-up less than one year. Cavazos et al identified 218 eyes with hyperopia > +5.00 D or astigmatism >+2.00 D. Of these, 82 (38%) of the dominant eyes had an initial corrected visual acuity less than 20/25. Most improved to > 20/25, but many patients were lost to follow-up. In ongoing studies, bilateral refractive amblyopia is being evaluated in Native Americans.
Patients will be enrolled who have bilateral refractive error with hyperopia >+4.00 D and/or astigmatism >2.00 D and have visual acuity in each eye, measured using best correction derived from cycloplegic refraction, meeting the following criteria:
- Using E-ETDRS testing for patients age 7 to <11 years: visual acuity 20 to 70 letters (20/40 to 20/400)
- Using ATS HOTV testing for patients age 3 to <7 years visual acuity 20/50 to 20/400
- Enrolled patients will be prescribed spectacles, which will be paid for by the study.
The patient will return for a Spectacle Baseline visit within 30 days, at which time the spectacles will be placed on the patient for the first time and binocular and monocular visual acuities will be measured.
- Patients whose monocular acuity at the Spectacle Baseline Visit is 20/25 or better in both eyes will end the study
- Patients whose monocular acuity at the Spectacle Baseline Visit is worse than 20/25 in at least one eye will begin a one-year period of study follow up
Follow-up visits are required at 5±:1 week, 13±:2 weeks, 26±:4 weeks, and 52±:4 weeks.
- If at any follow-up visit a patient's monocular acuity is 20/25 or better in both eyes, the patient should return for the 52-week visit only and may skip the interim follow-up visits.
Sample size: The study plans to enroll 100 patients. At least 50 patients will be enrolled who have an interocular difference of less than 3 lines by ATS HOTV or less than 15 letters by E-ETDRS at the Spectacle Baseline visit.
|Study Type :||Observational|
|Actual Enrollment :||113 participants|
|Official Title:||Bilateral Refractive Amblyopia Treatment Study|
|Study Start Date :||August 2004|
|Primary Completion Date :||July 2006|
|Study Completion Date :||October 2006|
- Visual acuity of 20/25 or better in both eyes [ Time Frame: 52 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00305955
|United States, North Carolina|
|Duke University Eye Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||David K. Wallace, M.D.||Duke University Eye Center|