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ACTIVE NOT RECRUITING
NCT06553404
PHASE4

Myoslow Lens Study to Control Myopia in Children

Sponsor: Crystal Optic

View on ClinicalTrials.gov

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

Official title: A Prospective, Randomized, Controlled Double Masked Trial to Assess the Performance of Myoslow Lens in Slowing Myopia Progression in Children

Key Details

Gender

All

Age Range

6 Years - 12 Years

Study Type

INTERVENTIONAL

Enrollment

125

Start Date

2022-11-24

Completion Date

2025-11-01

Last Updated

2024-08-14

Healthy Volunteers

No

Conditions

Interventions

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

Locations (1)

Sheba MC

Ramat Gan, Israel