A Clinical Trial Assessing the Safety and Effectiveness of Orthokeratology Lenses in Patients With Myopia and Myopic Astigmatism

A Prospective, Multi-centre, Single-Arm Clinical Trial of Orthokeratology Lenses (MCOK-01) in Subjects With Myopia and Myopic Astigmatism

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.

Inclusion Criteria:

1. Participant diagnosed with myopia and myopic astigmatism, documented by an eye care practitioner.
2. Participant is between 6-40 years old inclusive.
3. Participant is not motivated to wear glasses in daily life.
4. 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.
5. Provision of written informed consent.
6. Participants understand and agree to all requirements of the clinical trial; visit schedule, investigator guidance, follow-lens instructions, etc

Exclusion Criteria:

1. Best corrected distance vision acuity of less than 0.8 with spectacles.
2. Subjective refraction test shows spherical power greater than -6.00D,less than -0.50D or astigmatism greater than 1.5D.
3. Participants of East-Asian ethnicity (Chinese, Japanese, Korean, etc).
4. 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).
5. Medical history of intraocular surgery that may affect the effect of wearing the lens for this clinical trial (those with corneal transplantation, Retinal detachment, etc)..
6. Medical history of refractive corneal surgery.
7. Slit lamp findings that are more serious than grade 1
8. Participants requiring lens parameters outside of the scope of lens for this clinical trial.
9. Known eye allergies or conditions that are contraindicated, including sensitivity to any lens care maintenance or packaging solution additives being used in this study
10. Corneal abnormalities including keratoconus, corneal dystrophy and/or previous history of ocular herpes infections.
11. Currently using Atropine, or have used Atropine eye drops 14 days prior to enrolment.
12. For female participants, pregnancy, planned pregnancy during the trial or breastfeeding (pregnancy status provided by verbal confirmation).
13. Participation in other clinical trials or participation within the past 30 days.
14. Use of orthokeratology lenses within the prior 90 days, extended wear, rigid gas permeable corneal and scleral lenses within the prior 30 days, daily disposable and daily wear within the prior 15 days.
15. Mental incapacity.
16. Other Participants deemed not suitable for the trial at the investigator's discretion