NCT07229365

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
14mo left

Started Dec 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress25%
Dec 2025Jul 2027

First Submitted

Initial submission to the registry

November 12, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 17, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

December 22, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

November 12, 2025

Last Update Submit

April 29, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

SightGlass Vision Test Arm 1

EXPERIMENTAL

Single vision, impact-resistant spectacle lenses

Device: Novel spectacle lens design

SightGlass Vision Test Arm 2

EXPERIMENTAL

Single vision, impact-resistant spectacle lenses

Device: Spectacle lenses

Interventions

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

SightGlass Vision Test Arm 1

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

SightGlass Vision Test Arm 2

Eligibility Criteria

Age7 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University

Bloomington, Indiana, 47405, United States

RECRUITING

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2025

First Posted

November 17, 2025

Study Start

December 22, 2025

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

July 1, 2027

Last Updated

April 30, 2026

Record last verified: 2026-04

Locations