NIPH Clinical Trials Search

JRCT ID: jRCT2032220206

Registered date:08/07/2022

An evaluation test of Orthokeratology lenses(MCOK-01)

Basic Information

Recruitment status Not Recruiting
Health condition(s) or Problem(s) studiedMyopia or mild myopic astigmatism
Date of first enrollment01/06/2022
Target sample size91
Countries of recruitment
Study typeInterventional
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.


Primary OutcomeUnaided vision Amount of extension of axial length
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum>= 6age old
Age maximum<= 12age old
Include criteria1) 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 criteria1) 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


Public contact
Name Hiroyuki Yamaguchi
Address 21-19, Aoi 3 Naka-ku, Nagoya 460-0006 Japan Aichi Japan 460-0006
Telephone +81-52-933-6868
Affiliation Menicon Co., Ltd.
Scientific contact
Name Takahiro Hiraoka
Address 2-1-1, Amakubo, Tsukuba, Ibaraki 305-8576 Japan Ibaraki Japan 305-8576
Telephone +81-29-853-3900
Affiliation University of Tsukuba Hospital