This is a prospective, multi-centre, single-arm clinical trial to evaluate the effectiveness and safety of MCOK-01 lenses in patients with myopia and myopic astigmatism who need dioptric correction.
A maximum number of 220 participants are planned to be enrolled , with a minimum of 150 planned to complete the trial (30% dropout). All participants will be enrolled in Australia.
Enrolled participants will wear the lenses every night for up to 12 months, removing them upon waking. 8 follow up visits will be completed during treatment, after: 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 9 months and 12 months of wearing the lenses.
Participant diagnosed with myopia and myopic astigmatism, documented by an eye care practitioner.
Participant is between 6-40 years old inclusive.
Participant is not motivated to wear glasses in daily life.
Participants are of Caucasian ethnicity (must be >50% of study population) or other non-east Asian ethnic groups (Indian, Sri-Lankan, Pakistani, etc). Neither parent of participant can be east-asian.
Best corrected distance vision acuity of less than 0.8 with spectacles.
Subjective refraction test shows spherical power greater than -6.00D,less than -0.50D or astigmatism greater than 1.5D.
Participants of East-Asian ethnicity (Chinese, Japanese, Korean, etc).
Participants requiring treatment for eye disease other than refractive error (excluding those receiving artificial tears eye drops due to the wearing of corneal contact lenses).
Single group
MCOK-01
DeviceThe investigational device is a Rigid Gas Permeable contact lenses for orthokeratology. MCOK-01 applied the reverse geometry design and adopted the lens material which possesses the highest oxygen permeability among all the materials for orthokeratology lens.
Lines of improvement of monocular uncorrected distance visual acuity
Reading of a logMAR chart. Each line difference represents 0.1 logMAR acuity. The improvement in acuity is represented by a numerical reduction in the logMAR value.
Proportion of eyes achieved uncorrected distance visual acuity of ≤0.30 logMAR, ≤0.20 logMAR, ≤0.10 logMAR, and ≤0.00 logMAR
Measured using a logMAR chart. Each line difference represents 0.1 logMAR acuity. The improvement in acuity is represented by a numerical reduction in the logMAR value.
A level of attempted versus achieved reduction in manifest refractive error
Using a Phoropter/Refractor. Proportion of eyes with manifest sphere within ±0.50 D, ±1.00 D, and ±2.00 D of the target (plano)
Number and rates (by type of event and relation to device) of serious and significant adverse events
Adverse events will be self-reported by participants to investigative team
Improvement of monocular uncorrected distance visual acuity
Assessed with a logMAR chart. Endpoint will be measured by a set of descriptive statistics.
Change in best corrected spectacle visual acuity
Assessed using a logMAR chart
Changes in manifest sphere
Measured with a subjective refraction test
A level of attempted versus achieved reduction in manifest refractive error
Measured with a subjective refraction test. Proportion of eyes with manifest sphere within ±0.50 D, ±1.00 D, and ±2.00 D of the target (plano)
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