Myoslow Lens Study to Control Myopia in Children

Phase 4

Active, not recruiting

• Conditions: Myopia

• Registration Number: NCT06553404
• Lead Sponsor: Crystal Optic

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-24
• Study First Submitted: 2024-07-28
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-11
• Last Update Submitted: 2024-08-11
• Study First Posted: 2024-08-14
• Last Update Posted: 2024-08-14
• Primary Completion: 2025-10-01
• Study Completion: 2025-11-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 125

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
spherical equivalent error	24 months	Change in spherical equivalent refractive error from baseline to 24-month visit

Secondary Outcome Measures

Name	Time	Method
Axial length	24 months	Mean change in axial length (mm) from baseline at 24-month visit (Based on Biometry)

Trial Locations

Locations (1)

Sheba MC; 🇮🇱 Ramat Gan, Israel