Trials / Active Not Recruiting
Active Not RecruitingNCT06553404
Myoslow Lens Study to Control Myopia in Children
A Prospective, Randomized, Controlled Double Masked Trial to Assess the Performance of Myoslow Lens in Slowing Myopia Progression in Children
- Status
- Active Not Recruiting
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 125 (actual)
- Sponsor
- Crystal Optic · Industry
- Sex
- All
- Age
- 6 Years – 12 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Myoslow | 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. |
| DEVICE | Single Vision | Single vision glasses |
Timeline
- Start date
- 2022-11-24
- Primary completion
- 2025-10-01
- Completion
- 2025-11-01
- First posted
- 2024-08-14
- Last updated
- 2024-08-14
Locations
1 site across 1 country: Israel
Source: ClinicalTrials.gov record NCT06553404. Inclusion in this directory is not an endorsement.