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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07497672

Enrollment

Registered

2026-03-27

Start date

2026-04-15

Completion date

2026-12-15

Last updated

2026-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia: Refractive Error

Brief 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.

Interventions

DEVICEHabitual myopia glasses

Habitual myopia glasses of study P/905/25/MO

DEVICEMyopia Glasses A

Myopia glasses A of study P/905/25/MO

DEVICEMyopia Glasses B

Myopia glasses B of study P/905/25/MO

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

8 Years to 15 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026