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Recruiting NCT07229352

Mobility Performance in Daily Activities Among Children Wearing Spectacle Lenses

No phase Interventional Myopia Myopia Progression Juvenile Myopia

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: Novel spectacle lens design, Spectacle lenses.
Who it may be relevant to
Registry conditions: Myopia, Myopia Progression, Juvenile Myopia. Basic parameters: 6 years — 12 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
United States
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 →

Official title

Mobility Performance in Daily Activities Among Children Wearing Single Vision and Myopia Control Spectacle Lenses

Overview

The aim of this study is evaluate and compare the mobility performance of children in daily activities while wearing single vision spectacle lenses (control) versus myopia control spectacle lenses (test).

Interventions

  • Device Novel spectacle lens design
    Use of lenses may reduce the rate of progression of juvenile myopia
  • Device Spectacle lenses
    Use of lenses may reduce the rate of progression of juvenile myopia

Primary outcome measures

  • Reaction time: the time elapsed between the appearance or activation of a visual stimulus and the initiation of the participant's physical response [Time frame: 2 months]
  • Movement time: the time taken to complete the motor response after it has been initiated. [Time frame: 2 months]
  • Response accuracy: the correctness of the participant's response to each visual stimulus, measured by the number or percentage of correctly identified or responded-to stimuli. [Time frame: 2 months]
Secondary outcome measures (1)
  • Gait cycle events, such as initial foot contact with the ground and toe-off. It will be used to assess whether the type of eyewear affects natural gait patterns or mobility during peripheral vision tasks. [Time frame: 2 months]

Eligibility criteria

Inclusion criteria

A participant is eligible for inclusion in the study if they meet the following criteria:

  • Are between the ages of 6 and 12 years of age (inclusive) at the time of informed consent/assent.
  • Can achieve a corrected visual acuity of 20/20 best-corrected (or equivalent logMAR).
  • Have undergone a self-reported oculo-visual examination within the past two years.
  • Have no active ocular disease.
  • Are willing and able to adhere to instructions, study procedures, and maintain the appointment schedule.
  • Have not previously worn or participated in myopia control contact lenses for more than one month and are not currently undergoing any form of myopia control treatment.
  • The subject's parent(s) or legal guardian(s) must read, understand, and sign the Statement of Informed Consent and receive a fully executed copy of the form.

Exclusion criteria

A participant will be excluded from the study if they meet any of the following conditions:

  • Have any systemic disease that affects ocular health.
  • Are currently using or have used, within the past 7 days, any systemic or topical medications that may impact ocular health.
  • Are currently using or have used any topical ophthalmic agents with anti-muscarinic properties within 7 days prior to enrollment or at any point during the study. This includes, but is not limited to, atropine, scopolamine, pirenzepine, tropicamide, cyclopentolate, and homatropine.
  • Have used any oral agents with anti-muscarinic properties for a chronic period (2 months or more) or short-term (within 7 days prior to enrollment). This includes, but is not limited to, gastrointestinal anti-spasmodic medications containing atropine, hyoscyamine, and dicyclomine.
  • Have known developmental delays.
  • Have participated in another clinical study in the last 7 days

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

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Midwestern University Arizona College of Optometry — Glendale

Identifiers

NCT: NCT07229352 · CPRO-2507-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗