Mobility Performance in Daily Activities Among Children Wearing Spectacle Lenses

NCT ID: NCT07229352

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2026-07-01

Brief Summary

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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).

Detailed Description

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Conditions

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Myopia Myopia Progression Juvenile Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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SightGlass Vision Test Arm 1

Single vision, impact-resistant spectacle lenses

Group Type EXPERIMENTAL

Novel spectacle lens design

Intervention Type DEVICE

Use of lenses may reduce the rate of progression of juvenile myopia

SightGlass Vision Test Arm 2

Single vision, impact-resistant spectacle lenses

Group Type EXPERIMENTAL

Spectacle lenses

Intervention Type DEVICE

Use of lenses may reduce the rate of progression of juvenile myopia

Interventions

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Novel spectacle lens design

Use of lenses may reduce the rate of progression of juvenile myopia

Intervention Type DEVICE

Spectacle lenses

Use of lenses may reduce the rate of progression of juvenile myopia

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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SightGlass Vision, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Midwestern University Arizona College of Optometry

Glendale, Arizona, United States

Site Status

Countries

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United States

Central Contacts

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Jennifer Hill

Role: CONTACT

Phone: 6783614877

Email: [email protected]

Facility Contacts

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Javier Gantes-Nunez

Role: primary

Other Identifiers

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CPRO-2507-001

Identifier Type: -

Identifier Source: org_study_id