The Efficacy of 0.01% Atropine Ophthalmic Solution for Controlling the Progression of Childhood Myopia (ATOM-J Study)

Not Applicable

• Conditions: Mild or moderate myopia

• Registration Number: JPRN-jRCTs051180041
• Lead Sponsor: Kinoshita Shigeru

Brief Summary

From the results of this study, it was shown that once-daily administration of 0.01% atropine eye drops safely and effectively suppresses the progression of myopia in Japanese school children, but long-term administration is required for the effect to appear. In the future, it will be necessary to examine the optimal concentration of atropine and whether 0.01% atropine concentration is appropriate even for patients with small pupils.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-30
• Study Completion: 2019-09-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 171

Inclusion Criteria

(1) Male or female children aged 6 -to 12 years (elementary school grades 1-6) at the time of consent

(2) Children with a decrease in visual acuity in the vision assessment in a school physical examination within the past year.

(3) Children with a cycloplegic objective spherical equivalent of -1.00D to-6.00D in each eye

(4) Children with anisometropia within 1.50D.

(5) Children with astigmatism within +/- 1.50D

(6) Children with corrected visual acuity of at least 1.0

(7) Children with no intraocular pressure abnormalities

(8) Children capable of undergoing cycloplegia

(9) Children who can undergo outpatient examinations per protocol

(10) Written informed consent to participate in the study obtained from the child personally and from a person with parental authority

Exclusion Criteria

(1) Children with abnormal visual function bilaterally

(2) Children with amblyopia or manifest strabismus

(3) Children with difference in objective spherical equivalent with and without cycloplegia of more than 1.00D in each eye

(4) Children with ocular disorders other than myopia

(5) Children with ocular or systemic disorders that potentially affect myopia or refractive power

(6) Children who have received previous treatment for myopia that included atropine therapy such as contact lenses, bifocal lenses, or progressive lenses with atropine therapy (however, this does not apply to children who discontinued 0.4% tropicamide ophthalmic solution at least 3 months previously)

(7) Children with a history of cardiovascular or respiratory disease

(8) Children who have received pharmacotherapy for asthma in the past year

(9) Children with a history of allergy to atropine, cyclopentolate, or benzalkonium

(10) Children who cannot instill medication into the eye

(11) Children who may require contact lenses, bifocal lenses, or progressive lenses during the clinical study period

(12) Children deemed otherwise unsuitable for the study by the (sub)investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified