Myopia, Myopic Astigmatism
Conditions
Keywords
Myopia, Myopic Astigmatism, Orthokeratology Lenses, Orthokeratology
Brief summary
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.
Interventions
DEVICEMCOK-01
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.
Sponsors
Menicon Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lines of improvement of monocular uncorrected distance visual acuity | 12-months following enrolment | 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 | 1 month, 3 months, 6 months, 9 months, and 12 months following enrolment | 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 | 12 months following enrolment | 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 | Any time within the 12-months enrolment window | Adverse events will be self-reported by participants to investigative team |
| Number and rates (by type of event) of all types of adverse events that were not classified as serious or significant adverse events. | Any time within the 12-months enrolment window | Adverse events will be self-reported by participants to investigative team |
| Number of slit lamp results above grade 2 | 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months following enrolment | Assessed using a slit lamp |
| 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). | 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months following enrolment | Assessed with a logMAR chart |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number and rates of average wear time per day | 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months following enrolment | Patient reported at scheduled study visits |
| Increase in corneal or refractive astigmatism of 2D or more and 1D or more post-treatment | 12 months following enrolment | Measured with a subjective refraction test |
| Signs/symptoms and complications from subjective questionnaires | 1 month, 6 months, and 12 months following enrolment | Assessed by the subjective questionnaires completed by participants |
| Descriptive statistics of intraocular pressure (IOP) and for percent change from baseline | 6 months and 12 months following enrolment | Measured using a tonometer |
| Descriptive statistics of specular microscopy measurements | 12 months following enrolment | Measured using a specular microscope. Specific parameters include Endothelial Cell Morphology (Cell density (cells/mm2), Polymegethism (CV) and Pleomorphism (percentage of hexagonal cells)) |
| Improvement of monocular uncorrected distance visual acuity | 1 month, 3 months, 6 months, 9 months, and 12 months following enrolment | Assessed with a logMAR chart. Endpoint will be measured by a set of descriptive statistics. |
| Frequency and reasons for lens replacement | Any time within the 12-months enrolment window | Patient reported at scheduled study visits |
| 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 | 1 month and 3 months following enrolment | Measured with a subjective refraction test. Proportion of eyes with manifest sphere change within ±0.50 D between 1-month and 3-month visit. |
| Stability in unaided visual acuity | 1 month and 3 months following enrolment | 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. |
| Descriptive statistics of central corneal thickness | 6 months, and 12 months following enrolment | Measured using a specular microscope. |
| Change in best corrected spectacle visual acuity | 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months following enrolment | Assessed using a logMAR chart |
| Changes in manifest sphere | 1 month, 3 months, 6 months, 9 months, and 12 months following enrolment | Measured with a subjective refraction test |
| A level of attempted versus achieved reduction in manifest refractive error | 1 month, 3 months, 6 months, 9 months, and 12 months following enrolment | 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) |
| Corneal topography changes | 12 months following enrolment | Measured with a corneal topographer |
| Change in absolute corneal astigmatism | 12 months following enrolment | Measured with a corneal topographer |
| Number of discontinued participants and the reasons for discontinuation | Any time within the 12-months enrolment window | Ongoing participation rates will be continuously monitored |
Countries
Australia
Outcome results
None listed