Myopia or mild myopic astigmatism
Conditions
Interventions
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
Sponsors
Hiraoka Takahiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Unaided vision Amount of extension of axial length | — |
Contacts
Public ContactHiroyuki Yamaguchi
Menicon Co., Ltd.
Outcome results
None listed