Comparison of myopia control effects by combination therapy with multifocal SCL and atropine 0.01% ophthalmic solution, multifocal SCL monotherapy, combination therapy with sphere SCL and atropine 0.01% ophthalmic solution, versus sphere SCL monotherapy: a 1-year randomized four-armed clinical trial in myopic schoolchildre

Phase 4

Recruiting

• Conditions: myopia

• Registration Number: JPRN-jRCTs032200060
• Lead Sponsor: Takahiro Hiraoka

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

1) Male and female school children aged 6 to 12 at the time of obtaining consent (1st to 6th grade of elementary school)
2) School children who have visual acuity loss in their visual acuity judgment during the past 1 year
3) The results of the refractive test of both eyes under accommodative paralysis
-Both eyes have equivalent spherical power in the range of -1.00D to -6.00D
-The difference in equivalent spherical power between the left and right eyes is within 1.50D
-Astigmatic power is within plus/minus 1.00D
4) School children who are able to perform accommodation paralysis
5) School children who can receive medical examination according to this implementation plan
6) Schoolchildren who obtained informed consent from the person concerned and parental authority for participation in this study

Exclusion Criteria

1) School children with abnormal binocular function (Titmas stress test less than 5/9)
2) School children with amblyopia (corrected vision less than 1.0) or overt strabismus
3) Corrected visual acuity measured with glasses is less than 1.0
4) School children with abnormal intraocular pressure
5) School children with a difference in equivalent spherical power under controlled paralysis and non-regulated paralysis of 1.50 D or more for both eyes
6) School children with eye-related diseases other than myopia
7) School children with eye-related or systemic disorders that may affect visual acuity or power.
8) Multifocal contact lens, Bifocal glasses, progressive multifocal lens, orthokeratology lens, drug treatment, etc.
School children who have received myopia treatment
9) In addition, school children judged by the research responsibility doctor to be inappropriate for this study

Study & Design

• Study Type: Interventional
• Study Design: Not specified