Myoslow Lens Study to Control Myopia in Children

NCT ID: NCT06553404

Last Updated: 2024-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-24

Study Completion Date

2025-11-01

Brief Summary

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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

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Conditions

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

RCT
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
Participants and site staff will be masked to the assigned arm

Study Groups

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Single vision

Single vision glasses

Group Type ACTIVE_COMPARATOR

Single Vision

Intervention Type DEVICE

Single vision glasses

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.

Group Type EXPERIMENTAL

Myoslow

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Single Vision

Single vision glasses

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Crystal Optic

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Haim Stolovitch, MD

Role: STUDY_CHAIR

Crystal Optic

Locations

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Sheba MC

Ramat Gan, , Israel

Site Status

Countries

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Israel

Other Identifiers

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CLD-001

Identifier Type: -

Identifier Source: org_study_id

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