Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational | Experimental | All participants will be enrolled in the Investigational arm, and treated with the investigational product. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MCOK-01 | Device | The 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12-months following enrolment |
| 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. | 1 month, 3 months, 6 months, 9 months, and 12 months following enrolment |
| 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) | 12 months following enrolment |
| 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 | Any time within the 12-months enrolment window |
| Number and rates (by type of event) of all types of adverse events that were not classified as serious or significant adverse events. | Adverse events will be self-reported by participants to investigative team | Any time within the 12-months enrolment window |
| Number of slit lamp results above grade 2 | Assessed using a slit lamp |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of monocular uncorrected distance visual acuity | Assessed with a logMAR chart. Endpoint will be measured by a set of descriptive statistics. | 1 month, 3 months, 6 months, 9 months, and 12 months following enrolment |
| Change in best corrected spectacle visual acuity |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eyecare Kids | Hillsdale | New South Wales | 2036 | Australia |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009216 | Myopia |
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months following enrolment |
| Number and rate of cases of loss of; monocular best spectacle corrected visual acuity (BSCVA) of 2 or more lines (≥ 0.2 logMar), and 1 or more lines (≥ 0.1 logMar). | Assessed with a logMAR chart | 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months following enrolment |
Assessed using a logMAR chart |
| 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months following enrolment |
| Changes in manifest sphere | Measured with a subjective refraction test | 1 month, 3 months, 6 months, 9 months, and 12 months following enrolment |
| 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) | 1 month, 3 months, 6 months, 9 months, and 12 months following enrolment |
| Corneal topography changes | Measured with a corneal topographer | 12 months following enrolment |
| Change in absolute corneal astigmatism | Measured with a corneal topographer | 12 months following enrolment |
| Number of discontinued participants and the reasons for discontinuation | Ongoing participation rates will be continuously monitored | Any time within the 12-months enrolment window |
| Number and rates of average wear time per day | Patient reported at scheduled study visits | 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months following enrolment |
| Increase in corneal or refractive astigmatism of 2D or more and 1D or more post-treatment | Measured with a subjective refraction test | 12 months following enrolment |
| Signs/symptoms and complications from subjective questionnaires | Assessed by the subjective questionnaires completed by participants | 1 month, 6 months, and 12 months following enrolment |
| Descriptive statistics of intraocular pressure (IOP) and for percent change from baseline | Measured using a tonometer | 6 months and 12 months following enrolment |
| Descriptive statistics of specular microscopy measurements | Measured using a specular microscope. Specific parameters include Endothelial Cell Morphology (Cell density (cells/mm2), Polymegethism (CV) and Pleomorphism (percentage of hexagonal cells)) | 12 months following enrolment |
| Descriptive statistics of central corneal thickness | Measured using a specular microscope. | 6 months, and 12 months following enrolment |
| Frequency and reasons for lens replacement | Patient reported at scheduled study visits | Any time within the 12-months enrolment window |
| Damage or scratches on the lenses | 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months following enrolment |
| Stability in manifest refractive error | Measured with a subjective refraction test. Proportion of eyes with manifest sphere change within ±0.50 D between 1-month and 3-month visit. | 1 month and 3 months following enrolment |
| Stability in unaided visual acuity | Measured using a logMAR chart. Proportion of eyes with unaided visual acuity change within 1 line (0.1 logMAR) between 1-month and 3-month visit. | 1 month and 3 months following enrolment |
| UNSW School of Optometry and Vision Science | Sydney | New South Wales | 2052 | Australia |
|
| Queensland University of Technology Optometry and Vision Science | Kelvin Grove | Queensland | 4059 | Australia |
|
| The University of Melbourne Department of Optometry and Vision Sciences | Carlton | Victoria | 3053 | Australia |
|