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

NCT07497672 | Not Yet Recruiting FDA Device

• 1 other identifier: P/905/25/MO
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Myopia: Refractive Error

Outcome Measures

Primary Outcomes (1)

• Binocular visual acuity

  Binocular visual acuity with habitual myopia spectacle lens design and two test spectacle lens designs.

  20 minutes of wearing each lens design.

Study Arms (3)

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

Interventions

Habitual myopia glasses DEVICE

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

Habitual myopia glasses

Myopia Glasses A DEVICE

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

Myopia Glasses A

Myopia Glasses B DEVICE

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

Myopia Glasses B

Eligibility Criteria

• Age: 8 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• Current report of active ocular inflammation or infection.
• Astigmatism \> 1.00 D in either eye
• History of previous eye surgery

Sponsors & Collaborators

• Myoptechs, Inc: lead
• University of Waterloo School of Optometry and Vision Science: collaborator

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: March 27, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share