An evaluation test of Orthokeratology lenses(MCOK-01) for visual acuity correction and myopia control

Hiraoka Takahiro0 sites91 target enrollmentJuly 8, 2022

Overview

No summary available.

Registry

who.int

Start Date

July 8, 2022

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Hiraoka Takahiro

•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

•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