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
1 other identifier
interventional
125
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Nov 2022
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 24, 2022
CompletedFirst Submitted
Initial submission to the registry
July 28, 2024
CompletedFirst Posted
Study publicly available on registry
August 14, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2025
CompletedAugust 14, 2024
August 1, 2024
2.9 years
July 28, 2024
August 11, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
spherical equivalent error
Change in spherical equivalent refractive error from baseline to 24-month visit
24 months
Secondary Outcomes (1)
Axial length
24 months
Study Arms (2)
Single vision
ACTIVE COMPARATORSingle vision glasses
myoslow
EXPERIMENTALThe 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
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Eye and systemic disorders.
- Previously treated for myopia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Crystal Opticlead
Study Sites (1)
Sheba MC
Ramat Gan, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Haim Stolovitch, MD
Crystal Optic
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- Participants and site staff will be masked to the assigned arm
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2024
First Posted
August 14, 2024
Study Start
November 24, 2022
Primary Completion
October 1, 2025
Study Completion
November 1, 2025
Last Updated
August 14, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share
coded data only