NCT06553404

Myoslow Lens Study to Control Myopia in Children

Active, enrolled Phase 4 Last updated 14 August 2024

What this trial tests

Phase 4 trial testing Myoslow in Myopia in 125 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

24 November 2022

Primary endpoint
1 October 2025

1 November 2025

Quick facts

Lead sponsor	Crystal Optic
Phase	Phase 4
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	125
Start date	24 November 2022
Primary completion	1 October 2025
Estimated completion	1 November 2025
Sites	1 location across Israel

Drugs / interventions tested

• Myoslow
• Single Vision

Conditions studied

• Myopia — all drugs for Myopia →

Sponsor

Crystal Optic

Who can join

Adults 6 to 12, any sex, with Myopia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. New design peripheral defocus spectacle lens vs. single-vision for slowing myopia progression in children: randomized controlled trial.
   Wygnanski-Jaffe T, Shulman S, Gottesman N, Feit N, et al · · 2025 · PMID 41233497 · DOI 10.1038/s41598-025-23501-1