Bilateral Refractive Amblyopia Treatment Study (ATS7)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|