Children's Viewing Behavior

SightGlass Vision

Status: Enrolling

Conditions: Myopia; Myopia Progression; Juvenile Myopia

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT07229365

CPRO-2507-002

Details and patient eligibility

About

The aim of this study is to investigate the area of the spectacle lens in which a subject is viewing through regardless of task being performed.

Enrollment: 20 estimated patients

Sex: All

Ages: 7 to 14 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

A person is eligible for inclusion in the study if he/she:

• Is 7-14 years of age, inclusive
• Requires spherical spectacle lenses within the power range available for the study lenses
• Parent/guardian has read and understood the informed consent form, and the child has provided age-appropriate assent
• Is willing and able to follow instructions and maintain the appointment schedule
• Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best corrected
• Has had a self-reported oculo-visual examination in the last two years
• Spectacle cylinder of ≤ -0.75DC in both eyes

Exclusion criteria

A person will be excluded from the study if he/she:

• Is unable to complete the necessary study activities
• Has any systemic disease affecting ocular health
• Is using any systemic or topical medications (including pharmaceutical myopia control therapy) that will affect ocular health
• Is aphakic

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