Evaluation of Novel Spectacles Intended for Myopia Management in a Short-Term Study

NCT07497672 — Not applicable, Not yet recruiting, 20 participants, Myoptechs, Inc

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Registry	NCT07497672
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, crossover, masking: single, other
Enrollment	20 (Estimated)
Sponsor	Myoptechs, Inc (Industry); collaborators: University of Waterloo
Conditions	Myopia: Refractive Error
Interventions	Habitual myopia glasses, Myopia Glasses A, Myopia Glasses B (Device)
Dates	start 2026-04-15 (estimated), primary completion 2026-10-15 (estimated), completion 2026-12-15 (estimated), first posted 2026-03-27, last updated 2026-04-01

-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.

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+Arms and interventions

Arm	Type	Interventions
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

Habitual myopia glasses (Device): Habitual myopia glasses of study P/905/25/MO
Myopia Glasses A (Device): Myopia glasses A of study P/905/25/MO
Myopia Glasses B (Device): Myopia glasses B of study P/905/25/MO

+Outcome measures

Primary outcomes

Binocular visual acuity [20 minutes of wearing each lens design.]: Binocular visual acuity with habitual myopia spectacle lens design and two test spectacle lens designs.

+Eligibility

Sex: All, ages: 8 Years to 15 Years

Inclusion Criteria:

1. 8 - 15 years of age, inclusive.
2. Ability of the child to assent, and for one parent to provide permission to participate.
3. Had an eye examination within the past year.
4. Distance visual acuity of 20/25 (logMAR +0.10) or better in each eye with best corrected with sph/cyl subjective refraction.
5. 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.)
6. No history of binocular function anomaly (e.g., no history of strabismus), and no apparent strabismus.
7. 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).

Exclusion Criteria:

1. Current report of active ocular inflammation or infection.
2. Astigmatism > 1.00 D in either eye
3. History of previous eye surgery

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