NCT00305955

Bilateral Refractive Amblyopia Treatment Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 113 (actual)
• Sponsor: Jaeb Center for Health Research · Academic / Other
• Sex: All
• Age: 3 Years – 10 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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. 1. 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 2. Enrolled patients will be prescribed spectacles, which will be paid for by the study. 3. 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 4. 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.

Conditions

• Bilateral Refractive Amblyopia

Interventions

Type	Name	Description
DEVICE	Spectacles	optimal spectacle correction

Timeline

• Start date: 2004-08-01
• Primary completion: 2006-07-01
• Completion: 2006-10-01
• First posted: 2006-03-22
• Last updated: 2010-03-24

Locations

1 site across 1 country: United States