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

Phase 2

• Conditions: Myopia; refractive error, development, child; D009216

• Registration Number: JPRN-jRCTs061180091
• Lead Sponsor: Hasebe Satoshi

Brief Summary

This study suggests that the treatment of 0.01% atropine eye drops is effective in slowing myopia progression in children with moderate to high-grade myopia.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-22
• Study Completion: 2020-12-05
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 18

Inclusion 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

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Change in refractive error between baseline and final visits<br>2. Change in axial length of the eye between baseline and final visits

Secondary Outcome Measures

Name	Time	Method
occurrence of side effects