Augmenting Atropine Treatment for Amblyopia in Children 3 to < 8 Years Old

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to evaluate the effectiveness of adding a plano lens to weekend atropine after visual acuity has stabilized with weekend atropine but amblyopia is still present. Children ages 3 to <8 years with visual acuity of 20/50 to 20/400 in the amblyopic eye will be enrolled in a run-in phase with weekend atropine until no improvement, followed by randomization of eligible patients to weekend atropine treatment with a plano lens over the sound eye versus without a plano lens over the sound eye. The primary objective is to determine if adding a plano lens to weekend atropine will improve visual acuity in patients with amblyopia still present after visual acuity has stabilized with initial treatment.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jaeb Center for Health Research
• Collaborator: National Eye Institute (NEI)
• Treatments: Atropine

Criteria

Inclusion Criteria:

Major Eligibility Criteria for Run-in Phase

• Age 3 to < 8 years

• Amblyopia associated with strabismus, anisometropia, or both

• Visual acuity in the amblyopic eye between 20/50 and 20/400 inclusive

• Visual acuity in the sound eye 20/32 or better and inter-eye acuity difference >3 logMAR lines

• Amblyopia treatment within the past 6 months subject to the following stipulations:

• No more than 6 weeks of any amblyopia treatment other than spectacles (except for patients being treated with atropine who are entering the study on treatment)

• No simultaneous treatment with patching and atropine

• No use of atropine in combination with the sound eye spectacle lens reduced by more than 1.50 D

• Maximum level of treatment within the past 6 months:

• Patching: up to 2 hours daily

• Atropine: up to once daily

• Wearing spectacles with optimal correction (if amblyopic eye acuity is 20/80 or better, then VA must be stable in glasses; if amblyopic eye acuity is 20/100 or worse, then spectacles and atropine can be initiated simultaneously).

• Hypermetropia and spectacle correction in sound eye of +1.50 D or more

Eligibility Criteria for Randomization:

• Amblyopic eye acuity of 20/40 to 20/160 with an inter-ocular difference of >2 lines, or amblyopic eye acuity of 20/32 with 3 lines of IOD.

• Compliance with weekend atropine treatment based on investigator judgment.

Exclusion Criteria:

• Currently using vision therapy or orthoptics

• Ocular cause for reduced visual acuity (nystagmus per se does not exclude the patient if the above visual acuity criteria are met)

• Prior intraocular or refractive surgery

• Known allergy to atropine or other cycloplegic drugs

• Down Syndrome present