Menu
Not yet recruiting NCT07497672

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

No phase Interventional Myopia: Refractive Error

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Habitual myopia glasses, Myopia Glasses A, Myopia Glasses B.
Who it may be relevant to
Registry conditions: Myopia: Refractive Error. Basic parameters: 8 years — 15 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

  • Device Habitual myopia glasses
    Habitual myopia glasses of study P/905/25/MO
  • Device Myopia Glasses A
    Myopia glasses A of study P/905/25/MO
  • Device Myopia Glasses B
    Myopia glasses B of study P/905/25/MO

Primary outcome measures

  • Binocular visual acuity [Time frame: 20 minutes of wearing each lens design.]

Eligibility criteria

Inclusion criteria

  • 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).

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07497672 · P/905/25/MO

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗