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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Myopia
• Intervention / Treatment: Device: Single Vision; Device: Myoslow

• Study Type: Interventional
• Enrollment (Actual): 125
• Phase: Phase 4

Contacts and Locations

Study Locations

• Israel
  • Ramat Gan, Israel
    • Sheba MC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Single vision; Single vision glasses	Device: Single Vision; Single vision glasses
Experimental: 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: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
spherical equivalent error	Change in spherical equivalent refractive error from baseline to 24-month visit	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Axial length	Mean change in axial length (mm) from baseline at 24-month visit (Based on Biometry)	24 months

Collaborators and Investigators

• Sponsor: Crystal Optic
• Investigators: Study Chair: Haim Stolovitch, MD, Crystal Optic

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2022
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: July 28, 2024
• First Submitted That Met QC Criteria: August 11, 2024
• First Posted (Actual): August 14, 2024

Study Record Updates

• Last Update Posted (Actual): August 14, 2024
• Last Update Submitted That Met QC Criteria: August 11, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: CLD-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: coded data only

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No