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

Study Overview

• Status: Not yet recruiting
• Conditions: Myopia: Refractive Error
• Intervention / Treatment: Device: Habitual myopia glasses; Device: Myopia Glasses A; Device: Myopia Glasses B

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Habitual myopia glasses	Device: Habitual myopia glasses; Habitual myopia glasses of study P/905/25/MO
Experimental: Myopia Glasses A	Device: Myopia Glasses A; Myopia glasses A of study P/905/25/MO
Experimental: Myopia Glasses B	Device: Myopia Glasses B; Myopia glasses B of study P/905/25/MO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Myoptechs, Inc
• Collaborators: University of Waterloo School of Optometry and Vision Science

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2026
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): December 15, 2026

Study Registration Dates

• First Submitted: March 23, 2026
• First Submitted That Met QC Criteria: March 23, 2026
• First Posted (Actual): March 27, 2026

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: P/905/25/MO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes