high- or moderate-grade myopia
Conditions
Interventions
daily application of 0.01% atropine ophthalmic solution to the both eyes for 12 months
spectacle correction only
Sponsors
Kawasaki Medical School Department of Ophthalmology 2
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Children aged 6 to 12 years at the time of consent (2) Children with spherical equivalent refraction of -4.50 to-9.00 D in each eye (3) Children with anisometropia within 1.50 D. (4) Children with astigmatism within +/-1.50 D (5) Children with corrected visual acuity of at least 1.0 (6) Children with intraocular pressure equal to or lower than 21mmHg (7) Children capable of undergoing cycloplegia (8) Children who can undergo outpatient examinations per protocol (9) Written informed consent to participate in the study obtained from the child personally and a person with parental authority
Exclusion criteria
Exclusion criteria: (1) Children with abnormal binocular function (2) Children with amblyopia or manifest strabismus (3) Children with ocular disorders other than myopia (4) Children with ocular or systemic disorders that potentially affect myopia or refractive power (5) Children who have received previous treatment for myopia control that included atropine therapy, bifocal lenses, progressive lenses, and Ortho-K. (6) Children with a history of cardiovascular or respiratory disease (7) Children who have received pharmacotherapy for asthma in the past year (8) Children with allergy to atropine, cyclopentolate, or benzalkonium (9) Children who cannot use eye drops (10) Children who plans to use contact lenses during the follow-up period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in objectively-measured spherical equivalent refraction and axial length of the eye during the follow-up period of 12 months | — |
Countries
Japan
Contacts
Public ContactHasebe Satoshi
Kawasaki Medical School Department of Ophthalmology 2
Outcome results
None listed