MyopiaPhase 4NCT06553404
Myoslow Lens Study to Control Myopia in Children
A Phase 4 study testing Myoslow and Single Vision in people with Myopia, run by Crystal Optic at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Myopia
- What is being tested?
- Myoslow and Single Vision
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteIsrael
- Study dates
- 24 Nov 2022to 1 Nov 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Eye and systemic disorders.
- Previously treated for myopia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomized, Controlled Double Masked Trial to Assess the Performance of Myoslow Lens in Slowing Myopia Progression 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
- Conditions
- Myopia
- Being tested
- Myoslow, Single Vision
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyoslowDevice
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 VisionDevice
Single vision glasses
| Study group | Role | What they receive |
|---|---|---|
| Single vision | Active comparator | Single vision glasses Receives: Device: Single Vision |
| myoslow | Experimental | 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. Receives: Device: Myoslow |
What is being measured
The primary outcome is the main question the study is designed to answer.
spherical equivalent error
Change in spherical equivalent refractive error from baseline to 24-month visit
Measured: 24 months
Secondary outcomes (1)
Axial length
Mean change in axial length (mm) from baseline at 24-month visit (Based on Biometry)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2024
- Study start24 Nov 2022
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RCT
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Crystal Optic
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Haim Stolovitch, MD, Study chair, Crystal Optic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06553404
- Sponsor's protocol ID
- CLD-001
- Status last verified
- Aug 2024
- First submitted
- 28 Jul 2024
- Last updated
- 14 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: coded data only
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled Double Masked Trial to Assess the Performance of Myoslow Lens in Slowing Myopia Progression in Children
- ClinicalTrials.gov ID
- NCT06553404
- Acronym / sponsor ID
- CLD-001
- Conditions
- Myopia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Crystal OpticIndustry (pharma, biotech, devices)
- Study start
- 24 Nov 2022 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 14 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- RCT
| Arm | Type | Receives |
|---|---|---|
| Single vision | Active comparator | Device: Single VisionSingle vision glasses |
| myoslow | Experimental | Device: MyoslowThe 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. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Eye and systemic disorders.
- Previously treated for myopia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MyoslowThe 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. | Device | myoslow |
| Single VisionSingle vision glasses | Device | Single vision |
Primary outcome
spherical equivalent error
Time frame: 24 months
Change in spherical equivalent refractive error from baseline to 24-month visit
1 secondary outcome
Axial length
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
- Individual participant dataSharing planned: No. coded data only
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haim Stolovitch, MD study chair
Crystal Optic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Myoslow and Single Vision in people with Myopia, run by Crystal Optic at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
spherical equivalent error (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2024.