Mobility Performance in Daily Activities Among Children Wearing Spectacle Lenses

SightGlass Vision

Status: Not yet enrolling

Conditions: Myopia; Myopia Progression; Juvenile Myopia

Treatments: Device: Novel spectacle lens design; Device: Spectacle lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT07229352

CPRO-2507-001

Details and patient eligibility

About

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).

Enrollment: 20 estimated patients

Sex: All

Ages: 6 to 12 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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20 participants in 2 patient groups

SightGlass Vision Test Arm 1

Experimental group

Description:

Single vision, impact-resistant spectacle lenses

Treatment:

Device: Novel spectacle lens design

SightGlass Vision Test Arm 2

Experimental group

Description:

Single vision, impact-resistant spectacle lenses

Treatment:

Device: Spectacle lenses