Suppression of myopia progression in low-concentration atropine

JRCT ID: jRCTs051180170

Registered date:26/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Mild or moderate myopia
• Date of first enrollment: 13/03/2014
• Target sample size: 150
• Study type: Interventional

Intervention(s)

Individual subjects randomly received 0.01% atropine, 0.025% cyclopentrate, saline
Instillation once a day before going to bed. Then observe the progress every six months.

Outcome(s)

Primary Outcome

Change from baseline in objective spherical equivalent at the end of 24 months
of drug treatment.

• Secondary Outcome: Change from baseline in axial length at the end of 24 months of drug treatment.

Key inclusion & exclusion criteria

• Age minimum: >= 6age old
• Age maximum: <= 12age old
• Gender: Both

Include criteria

Objective spherical equivalent under cycloplegia -1 D to -6 D
Corrected distance visual acuity 0.7 or more

Exclude criteria

Anisometropy exceeds 1.5D, astigmatism exceeds 1.5D
Strabismus, amblyopia

Related Information

• Primary Sponsor: Kinoshita Shigeru
• Source(s) of Monetary Support: Menicon Co., Ltd.,Menicon Co., Ltd.
• Secondary ID(s): UMIN000015991