An evaluation test of Orthokeratology lenses(MCOK-01)

JRCT ID: jRCT2032220206

Registered date:08/07/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Myopia or mild myopic astigmatism
• Date of first enrollment: 01/06/2022
• Target sample size: 91
• Study type: Interventional
• Intervention(s): Enrolled subjects will be randomly assigned to one of test group A, test group B, control group, and lenses or glasses will be prescribed according to the assignment results. Subjects of test group A will wear study lenses for 24 months, and subjects of test group B will wear them for 12 months.

Outcome(s)

Primary Outcome

Unaided vision
Amount of extension of axial length

Key inclusion & exclusion criteria

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

Include criteria

1) Subjects who need vision correction for their binoculus due to myopia or mild myopic astigmatism
2) subject who are 6 age over and 12 age under except pre-schoolchild
3) Subjects whose spherical equivalent power of their binoculus is -0.75 to -4.00 D in the cycloplegic objective refraction test
4) Subjects whose cylindrical diopter of their binoculus is -1.50 D or less in the cycloplegic objective refraction test
5) Subjects whose refractive power in the center of the cornea of their binoculus is 39.00 - 48.00D
6) Subject who have healthy eyes that does not show marked fluorescein dyeing in the cornea, over 5 seconds in tear fluid test, are 2,500/mm2 and over in corneal endothelial cell density

Exclude criteria

1) Subject who does not apply to inclusion criteria
2) Subject who does not show informed assent or whose parents does not show informed consent
3) Subject who cannot visit to hospital following schedule
4) Subject with immune disorders (AID, Autoimmune disorders) or diabetes
5) Subject who have possibility to have allergic reaction at ocular surface or eye adnexa or get worse due to wear contact lenses or use care products
6) Subject with acute or subacute inflammation or bacterial, mycotic or viral keratoconjunctivitis
7) Subject with diseases of cornea, conjunctiva or eyelid or damage or odd shape that affect them
8) Subjects with serious dry eye
9) Subject with loosing corneal perception
10) Subjects who show unstable corneal refractive power or very dishonest meyer statue
11) Subject with a history of eye surgery (corneal transplant, detachment of retina, corneal refractive surgery) affect vision after clinical trial
12) Subject who usually use contact lenses
13) Subject whose best corrected vision in subjective refraction test is less than 1.0D
14) Subject whose difference in refractive power between right and left eye is 1.50D and over in the cycloplegic objective refraction test
15) Subject who join other clinical trials or joined that within the past 30days
16) Subject who wore perspective glasses or orthokeratology lenses or had medicine or supplement related with regulatory factors such as atropine in the past
17) Subject who have a plan to go into hospital or have surgery during clinical trials
18) Subject whom An investigator considers that get in on clinical trials is inadequate

Related Information

• Primary Sponsor: Hiraoka Takahiro