Myopia: Refractive ErrorNCT07497672
Evaluation of Novel Spectacles Intended for Myopia Management in a Short-Term Study
A study testing Habitual myopia glasses, Myopia Glasses A and Myopia Glasses B in people with Myopia: Refractive Error, run by Myoptechs, Inc.
Trial summary
The primary objective of this study is to evaluate the visual acuity, wearability, and quality of vision with two novel multifocal glasses designs in habitual myopia control glasses wearers, in a non-dispensing study after short-term wear. Read more about this study
- Who is it for?
- Ages 8 to 15 years
- Conditions the study is for
- Myopia: Refractive Error
- What is being tested?
- Habitual myopia glasses, Myopia Glasses A and Myopia Glasses B
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2026to 15 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 8 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 8 - 15 years of age, inclusive.
- Ability of the child to assent, and for one parent to provide permission to participate.
- Had an eye examination within the past year.
- Distance visual acuity of 20/25 (logMAR +0.10) or better in each eye with best corrected with sph/cyl subjective refraction.
- Habitual glasses wearer of either MiYOSMART or Stellest for at least 2 months. (Can also be a contact lens wearer but needs to wear either MiYOSMART or Stellest spectacles for a minimum of 6 hours on a typical day.)
- No history of binocular function anomaly (e.g., no history of strabismus), and no apparent strabismus.
- Good general health (defined by medication use that has not changed within the last month and the absence of medical conditions or treatments that are deemed confounding to the data, as determined by the investigator).
Who cannot join
- Current report of active ocular inflammation or infection.
- Astigmatism > 1.00 D in either eye
- History of previous eye surgery
About this study
The primary objective of this study is to evaluate the visual acuity, wearability, and quality of vision with two novel multifocal glasses designs in habitual myopia control glasses wearers, in a non-dispensing study after short-term wear.
- Conditions
- Myopia: Refractive Error
- Being tested
- Habitual myopia glasses, Myopia Glasses A, Myopia Glasses B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Habitual myopia glassesDevice
Habitual myopia glasses of study P/905/25/MO
Myopia Glasses ADevice
Myopia glasses A of study P/905/25/MO
Myopia Glasses BDevice
Myopia glasses B of study P/905/25/MO
| Study group | Role | What they receive |
|---|---|---|
| Habitual myopia glasses | Active comparator | Not described Receives: Device: Habitual myopia glasses |
| Myopia Glasses A | Experimental | Not described Receives: Device: Myopia Glasses A |
| Myopia Glasses B | Experimental | Not described Receives: Device: Myopia Glasses B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binocular visual acuity
Binocular visual acuity with habitual myopia spectacle lens design and two test spectacle lens designs.
Measured: 20 minutes of wearing each lens design.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start15 Apr 2026 (estimated)
- Primary completion15 Oct 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myopia: Refractive ErrorStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Myoptechs, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Waterloo
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07497672
- Sponsor's protocol ID
- P/905/25/MO
- Status last verified
- Mar 2026
- First submitted
- 23 Mar 2026
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: The results are regarded as confidential to our business as Sponsor, and confidential for the selection of one device to use in a future study. There are no plans for a public data repository for this study.
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Novel Spectacles Intended for Myopia Management in a Short-Term Study
- ClinicalTrials.gov ID
- NCT07497672
- Acronym / sponsor ID
- P/905/25/MO
- Conditions
- Myopia: Refractive Error
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Myoptechs, IncIndustry (pharma, biotech, devices)
- Collaborators
- University of Waterloo
- Study start
- 15 Apr 2026 (estimated)
- Primary completion
- 15 Oct 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 27 Mar 2026 (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.
The primary objective of this study is to evaluate the visual acuity, wearability, and quality of vision with two novel multifocal glasses designs in habitual myopia control glasses wearers, in a non-dispensing study after short-term wear.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Habitual myopia glasses | Active comparator | Device: Habitual myopia glasses |
| Myopia Glasses A | Experimental | Device: Myopia Glasses A |
| Myopia Glasses B | Experimental | Device: Myopia Glasses B |
Who may qualify
- Ages
- 8 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 8 - 15 years of age, inclusive.
- Ability of the child to assent, and for one parent to provide permission to participate.
- Had an eye examination within the past year.
- Distance visual acuity of 20/25 (logMAR +0.10) or better in each eye with best corrected with sph/cyl subjective refraction.
- Habitual glasses wearer of either MiYOSMART or Stellest for at least 2 months. (Can also be a contact lens wearer but needs to wear either MiYOSMART or Stellest spectacles for a minimum of 6 hours on a typical day.)
Key exclusion criteria (3 listed)
- Current report of active ocular inflammation or infection.
- Astigmatism > 1.00 D in either eye
- History of previous eye surgery
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 |
|---|---|---|
| Habitual myopia glassesHabitual myopia glasses of study P/905/25/MO | Device | Habitual myopia glasses |
| Myopia Glasses AMyopia glasses A of study P/905/25/MO | Device | Myopia Glasses A |
| Myopia Glasses BMyopia glasses B of study P/905/25/MO | Device | Myopia Glasses B |
Primary outcome
Binocular visual acuity
Time frame: 20 minutes of wearing each lens design.
Binocular visual acuity with habitual myopia spectacle lens design and two test spectacle lens designs.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: No. The results are regarded as confidential to our business as Sponsor, and confidential for the selection of one device to use in a future study. There are no plans for a public data repository for this study.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Habitual myopia glasses, Myopia Glasses A and Myopia Glasses B in people with Myopia: Refractive Error, run by Myoptechs, Inc.
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 7 inclusion and 3 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: opening soon, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Binocular visual acuity (time frame: 20 minutes of wearing each lens design.). 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 1 Apr 2026.