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OpenTrials
Active, not recruiting

NCT Number: NCT06553404

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.

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

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sheba MC

Ramat Gan, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Myoslow

Device

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.

Single Vision

Device

Single vision glasses

Primary outcomes

  1. spherical equivalent error

    Time frame: 24 months

    Change in spherical equivalent refractive error from baseline to 24-month visit

Secondary outcomes

  1. Axial length

    Time frame: 24 months

    Mean change in axial length (mm) from baseline at 24-month visit (Based on Biometry)

Interested in participating?

Active, not recruiting

This study is active but is not currently recruiting participants.

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Sponsors and collaborators

Lead sponsor

Crystal Optic

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Aug 14, 2024
Registry last updated
Aug 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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