A prospective, multicenter, randomized, controlled clinical trial of orthokeratology lens
The test product is the orthokeratology lens, and the control product is a commercially available orthokeratology lens. The number of enrolled subjects is 390, and clinical observation is performed for 12 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
390
Randomized to test orthokeratology lens worn during sleep every night
Randomized to control orthokeratology lens worn during sleep every night
I&VISION Research Centre
Singapore, Singapore
Myopia Specialist Centre
Singapore, Singapore
Stan Isaacs
Singapore, Singapore
Visual acuity
uncorrected visual acuity measured using logMAR chart
Time frame: 1 year
Axial length
axial eye length in millimeter measured by MYAH (Topcon) and IOL master (ZEISS)
Time frame: 1 year
Refraction
spherical and cylinder power in diopter for best corrected visual acuity measured subjectively
Time frame: 1 year
Adverse Events
Adverse events are classified into moderate, middle, or severe.
Time frame: 1 year
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