Effect of 0.01% atropine eye drops in children with moderate to high grade myopia

JRCT ID: jRCTs061180091

Registered date:22/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Myopia
• Date of first enrollment: 24/03/2018
• Target sample size: 50
• Study type: Interventional
• Intervention(s): An atropine eye drop/ day is applied on both eyes at night

Outcome(s)

Primary Outcome

1. Change in refractive error between baseline and final visits
2. Change in axial length of the eye between baseline and final visits

• Secondary Outcome: occurrence of side effects

Key inclusion & exclusion criteria

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

Include criteria

1.Age at base line: 5-12 years
2.Spherical equivalent under cycloplegia: both eyes from -4.50 to -9.00D
3.Aniseiconia =<1.50 D
4.Astigmatism =<1.50 D
5.Best corrected visual acuity = or >1.0
6.Inter ocular pressure = or <21mmHg
7.Willing to undergo cycloplegia
8.Written informed consent by the child and parent

Exclude criteria

1.Abnormal binocular function
2.Amblyopia or manifest strabismus
3.Anisometropia >1.00D
4.Eye diseases besides myopia
5.ophthalmic and/or systematic diseases that may influence on visual acuity or refractive error
6.Previous history of using atropine, contact lenses, bifocal or progressive addition lenses, or ortho-K
7.Eye or general diseases that may affect myopia progression
8.History of asthma treatment within 1 year.
9.Allergic history to atropine, cyclopentolate, or benzalkonium
10.Difficult to use eye drops
11.A plan to use contact lenses

Related Information

• Primary Sponsor: Hasebe Satoshi
• Source(s) of Monetary Support: Ministry of Education, Culture, Sports, Science and Technology,Kawasaki Medical School
• Secondary ID(s): UMIN000028553