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 schoolchildren

JRCT ID: jRCTs032200060

Registered date:30/06/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: myopia
• Date of first enrollment: 23/08/2021
• Target sample size: 240
• Study type: Interventional

Intervention(s)

1) Group A: group wearing multifocal contact lens + 0.01% atropine ophthalmic solution
Baseline observation at enrollment and wearing multifocal contact lenses for 12 months. For the test drug, 0.01% atropine ophthalmic solution is to be instilled once a day in both eyes for 12 months after baseline observation before bedtime.
2) Group B: Multifocal contact lens wearing + placebo eye drop administration group
Baseline observation at enrollment and wearing multifocal contact lenses for 12 months. For the study drug, placebo eye drops are to be instilled once a day in both eyes for 12 months after baseline observation before bedtime.
3) Group C: Single focus contact lens wearing + 0.01% atropine eye drop administration group
A baseline observation is made at the time of enrollment, and a single focus contact lens is worn for 12 months. For the test drug, 0.01% atropine ophthalmic solution is to be instilled once a day in both eyes for 12 months after baseline observation before bedtime.
4) Group D: Single focus contact lens wearing + placebo eye drop administration group
A baseline observation is made at the time of enrollment, and a single focus contact lens is worn for 12 months. For the study drug, placebo eye drops are to be instilled once a day in both eyes for 12 months after baseline observation before bedtime.

Outcome(s)

• Primary Outcome: A significant difference in axial elongation and myopia progression over one year between group A and group B. (Axial elongation and myopia progression in the combination therapy group with multifocal SCL and atropine ophthalmic solution is significantly smaller than those in the multifocal SCL monotherapy group.)

Secondary Outcome

1) Amount of change in axial length from the time of baseline observation to each time after the start of treatment
2) The amount of change in the refractive index from the time of baseline observation to each time point after the start of treatment
3) Amount of change in equivalent spherical power from the time of baseline observation to each time point after the start of treatment

Key inclusion & exclusion criteria

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

Include 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

Exclude 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

Related Information

• Primary Sponsor: Takahiro Hiraoka
• Source(s) of Monetary Support: Johnson and Johnson Vision Care