Mobility Performance in Daily Activities Among Children Wearing Spectacle Lenses

April 29, 2026 updated by: SightGlass Vision, Inc.

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Glendale, Arizona, United States, 85308
        • Recruiting
        • Midwestern University Arizona College of Optometry
        • Contact:
          • Javier Gantes-Nunez

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SightGlass Vision Test Arm 1
Single vision, impact-resistant spectacle lenses
Device: Novel spectacle lens design
Use of lenses may reduce the rate of progression of juvenile myopia
Experimental: SightGlass Vision Test Arm 2
Single vision, impact-resistant spectacle lenses
Device: Spectacle lenses
Use of lenses may reduce the rate of progression of juvenile myopia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
2 months
Movement time: the time taken to complete the motor response after it has been initiated.
Time Frame: 2 months
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
2 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SightGlass Vision, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

November 12, 2025

First Submitted That Met QC Criteria

November 12, 2025

First Posted (Actual)

November 17, 2025

Study Record Updates

Last Update Posted (Actual)

April 30, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPRO-2507-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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