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Sponsored by: |
National Eye Institute (NEI) |
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Information provided by: | National Eye Institute (NEI) |
ClinicalTrials.gov Identifier: | NCT00305955 |
The purpose of this study will be to:
Condition | Intervention | Phase |
---|---|---|
Bilateral Refractive Amblyopia |
Device: Spectacles |
Phase III |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | Bilateral Refractive Amblyopia Treatment Study |
Enrollment: | 113 |
Study Start Date: | August 2004 |
Study Completion Date: | July 2006 |
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
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:
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.
Follow-up visits are required at 5±:1 week, 13±:2 weeks, 26±:4 weeks, and 52±:4 weeks.
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.
Ages Eligible for Study: | 3 Years to 10 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Study ID Numbers: | NEI-101 |
Study First Received: | March 20, 2006 |
Last Updated: | November 13, 2007 |
ClinicalTrials.gov Identifier: | NCT00305955 History of Changes |
Health Authority: | United States: Federal Government |
amblyopia bilateral amblyopia refractive error |
Signs and Symptoms Sensation Disorders Vision Disorders Amblyopia Eye Diseases |
Neurologic Manifestations Central Nervous System Diseases Brain Diseases Refractive Errors |
Signs and Symptoms Sensation Disorders Vision Disorders Amblyopia Eye Diseases |
Nervous System Diseases Neurologic Manifestations Central Nervous System Diseases Brain Diseases |