Children's Viewing Behavior

Children's Viewing Behavior in Myopia Control Spectacles

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.

Study Overview

• Status: Recruiting
• Conditions: Myopia; Myopia Progression; Juvenile Myopia
• Intervention / Treatment: Device: Novel spectacle lens design; Device: Spectacle lenses

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jennifer Hill; Phone Number: 6783614877; Email: jhill@sightglassvision.com

Study Locations

• United States
  • Indiana
    • Bloomington, Indiana, United States, 47405
      • Recruiting
      • Indiana University
      • Contact: Pete S Kollbaum, OD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

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
Activity dependent, gaze location in myopia control spectacles	2 months
Subjective/objective quantification of activity via survey or observation	2 months
Pupil size	2 months

Collaborators and Investigators

• Sponsor: SightGlass Vision, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2025
• Primary Completion (Estimated): December 30, 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: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: CPRO-2507-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes