Health Condition 1: H521- Myopia
Conditions
Interventions
Intervention1: Menicon Bloom Night lenses: Menicon Bloom Nightâ?¢ (MBN) is the first ortho-k lens which is CE-approved specifically for Myopia Control in Europe. It involves the overnight wear of a sp
Sponsors
Menicon Co Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients with myopia and myopic astigmatism. 2.Patients aged between above or equal to 6 and under or equal to 15 years old at baseline examination. 3.Keratometry: 37 to 52 D (diopter) 4.Fully understand the purpose of the clinical study and agree to sign the informed consent form to participate in clinical study, based on his/her willingness. 5.Patients who can visit the institution on scheduled dates 6.Patients who can receive guidance and tests as required by the investigator 7.Patients who fully understand and follow the instructions of the lenses for this clinical study
Exclusion criteria
Exclusion criteria: 1. Best corrected vision acuity of more than 0.1 logMAR (less than 6/7.5 Snellen) with spectacles 2. Subjective refraction test shows spherical power greater than -4.00D, less than -0.50D or astigmatism greater than 1.5D or anisometropia greater than 1.5D. 3. Presence of Strabismus at distance or near 4. Patients in need of treatment for eye disease other than refractive error (excluding those receiving artificial tears eye drops due to the wearing of corneal contact lenses) 5. The medical history of intraocular surgery that may affect the effect of wearing orthokeratology lenses (those with corneal transplantation, retinal detachment, etc.) 6. The medical history of refractive corneal surgery 7. Having eye allergic diseases that may cause disorders in wearing orthokeratology lenses 8. All corneal abnormalities including keratoconus, corneal dystrophy, previous history of ocular herpes infections, low corneal endothelial cell counts 9. Patients who are participating in other clinical studies or have participated in other clinical studies in the past 30 days 10. Prior experience with use of rigid lenses within the previous 3 weeks or use of soft lenses within the previous 3 days 11. Prior history of myopia control treatment within 06 months (e.g. atropine, orthokeratology, multifocal soft contact lenses, spectacles designed for myopia control, red light therapy) 12. Deemed inappropriate for participation in this study by an ophthalmologist after detailed eye health check
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary effectiveness endpoints: 1. Axial elongation (for Myopia control efficacy): [Timeframe: Screening, month 03, 06 and 12] 2. Visual acuity (for Myopia correction efficacy): [Timeframe: Screening, week 03, month 03, 06 and 12] 3. Cycloplegic Refraction(for Myopia correction efficacy): [Timeframe: Screening, month 06 and 12] 4. Slit lamp findings (for Safety): [Timeframe: Screening, week 03, month 03, 06 and 12] 5. IOP (for Safety): [Timeframe: Screening, month 12] 6. Corneal endothelial cell (for Safety): [Timeframe: Screening,month 12] 7. Central corneal thickness (for Safety): [Timeframe: Screening, month 12] 8. Adverse Event Monitoring (for Safety): [Timeframe: Screening, lens allocation, day 01, week 01 and 03, Month 03, 06 and 12Timepoint: Primary effectiveness endpoints: 1. Axial elongation (for Myopia control efficacy): [Timeframe: Screening, month 03, 06 and 12] 2. Visual acuity (for Myopia correction efficacy): [Timeframe: Screening, week 03, month 03, 06 and 12] 3. Cycloplegic Refraction(for Myopia correction efficacy): [Timeframe: Screening, month 06 and 12] 4. Slit lamp findings (for Safety): [Timeframe: Screening, week 03, month 03, 06 and 12] 5. IOP (for Safety): [Timeframe: Screening, month 12] 6. Corneal endothelial cell (for Safety): [Timeframe: Screening, month 12] 7. Central corneal thickness (for Safety): [Timeframe: Screening, month 12] 8. Adverse Event Monitoring (for Safety): [Timeframe: Screening, lens allocation, day 01, week 01 and 03, Month 03, 06 and 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Corneal Topography (Test group & Control group1) 2. Corneal endothelial cell (for Safety) (Test group & Control group1) 3. Central corneal thickness (for Safety) (Test group & Control group1) 4. Lens condition (for Test group & Control group1) Lens inspection with slit lamp 5. Satisfaction Questionnaire for Patients & Parents 6. Satisfaction Questionnaire for ECP 7. Adherence/Compliance Questionnaire for all group (Wearing time monitoring)Timepoint: 1. Screening, day01, week 01 & 03, month 03, 06 & 12 2. Screening, month 06 3. Screening, month 06 4. Day 01, week 01 & 03, Month 03, 06 & 12 5. Week 03, month 06 & 12 6. Screening & month 12 7. Week 03, Month 06 & 12;8. Spectacle Wearing time (Eye Care clip) (for Control group 2 and 3)Timepoint: Week 03, Month 06 & 12 | — |
Countries
India
Contacts
Public ContactDr Mukul Maurya
Menicon Co. Ltd.
Outcome results
None listed