Myoslow Lens Study to Control Myopia in Children

Crystal Optic

Status and phase: Active, not recruiting; Phase 4

Conditions: Myopia

Treatments: Device: Single Vision; Device: Myoslow

Study type: Interventional

Funder types: Industry

Identifiers

NCT06553404

CLD-001

Details and patient eligibility

About

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

Enrollment: 125 patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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125 participants in 2 patient groups

Single vision

Active Comparator group

Description:

Single vision glasses

Treatment:

Device: Single Vision

myoslow

Experimental group

Description:

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.

Treatment:

Device: Myoslow