Treatment of Residual Amblyopia With Donepezil

Inclusion Criteria:

1. Age ≥8 years

2. Amblyopia associated with strabismus and/or anisometropia

3. Amblyopic eye visual acuity of 20/50 - 20/400

4. Sound eye visual acuity of ≥20/25

5. For 8 to 17 year olds, current amblyopia treatment of at least 2 hours of daily
patching for at least 4 weeks during the pre-enrollment period with no improvement in
best-corrected amblyopic eye visual acuity (<5 letters or 1 logMAR line between 2
consecutive visual acuity measurements at least 4 weeks apart while on current
treatment)

6. For ≥18 year olds, history of prior amblyopia treatment with patching

7. Wearing optimal optical correction with stable amblyopic eye visual acuity (<5 letters
or 1 logMAR line of improvement during 2 consecutive visual acuity measurements at
least 4 weeks apart)

8. Complete eye examination within 6 months prior to enrollment

9. Available for at least 6 months of follow-up, have access to a phone, and willing to
be contacted by clinical staff

10. Likely to comply with prescribed treatment and unlikely, if applicable, to continue to
improve with 2 hours of daily patching alone

Exclusion Criteria:

1. Myopia more than -6.00 D spherical equivalent

2. Presence of associated findings that could cause reduced visual acuity

3. Previous intraocular or refractive surgery

4. Strabismus surgery planned within 22 weeks

5. Current vision therapy or orthoptics

6. Treatment with topical atropine within the past 4 weeks

7. Presence of cardiac condition, asthma, obstructive pulmonary disease, seizure
disorder, urinary incontinence, and/or peptic ulcer disease receiving concurrent
NSAIDs

8. History of gastrointestinal bleeding from peptic ulcer disease

9. Known psychological problems

10. Known skin reaction to patch or bandage adhesives for 8 to 17 year olds

11. Known allergies or contraindications to the use of acetylcholinesterase inhibitors

12. Prior acetylcholinesterase inhibitor treatment

13. Current use of medication for the treatment of ADHD or psychological disorders

14. Inability to swallow pills equivalent in size to the 5 mg donepezil tablet

15. Females who are pregnant, lactating, or intending to become pregnant within the next 6
months