Myopia
Conditions
Brief summary
A Prospective, randomized, controlled double masked trial to assess the performance of Myoslow lens in slowing myopia progression in children. The following study measures will be assessed: * Demographics and medical history * Current spectacles * Best Corrected Visual Acuity (BCVA) assessed by Measurement and Summation (M&S) system * Biometry * Cover test * Stereopsis * Ocular Motility * Pupil responses * Cycloplegic refraction * Fundus Examination * Vision related quality of life using the questionnaire Pediatric Refractive Error Profile (PREP)2 * Adverse Events
Interventions
DEVICEMyoslow
The Myoslow spectacle lens is based on the Defocus Incorporated Multiple Segments (DIMS) mechanism of action. This lens provides the same optical image as the Defocusing Incorporated Soft Contact Lens (DISC) without the drawbacks inherent with contact lens fitting.
DEVICESingle Vision
Single vision glasses
Sponsors
Crystal Optic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Participants and site staff will be masked to the assigned arm
Intervention model description
RCT
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* Children, 6-12 years old * Spherical Equivalence Refraction (SER): -1.00 to -5.00 Diopter (D). * Astigmatism and anisometropia of 1.50 D or less. * Best Corrected Visual Acuity (BCVA) (6 / 7.5) or higher.
Exclusion criteria
* Eye and systemic disorders. * Previously treated for myopia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| spherical equivalent error | 24 months | Change in spherical equivalent refractive error from baseline to 24-month visit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Axial length | 24 months | Mean change in axial length (mm) from baseline at 24-month visit (Based on Biometry) |
Countries
Israel
Outcome results
None listed