Recruiting

Single Vision vs. Myopia Control

Sponsor:

SightGlass Vision, Inc.

Code:

NCT07229352

Conditions

Myopia

Myopia Progression

Juvenile Myopia

Eligibility Criteria

Sex: All

Age: 6 - 12

Healthy Volunteers: Accepted

Interventions

Novel spectacle lens design

Spectacle lenses

Study Details

Brief summary:

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).

Conditions

Myopia

Myopia Progression

Juvenile Myopia

Study ID

NCT07229352

Start date

Feb 2, 2026

Status verified date

Apr, 2026

Completion date

Jul 1, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 12

Healthy Volunteers: Accepted

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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: SightGlass Vision Test Arm 1

Single vision, impact-resistant spectacle lenses

experimental: SightGlass Vision Test Arm 2

Single vision, impact-resistant spectacle lenses

Interventions

Novel spectacle lens design

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

Spectacle lenses

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

Primary outcome measure

  • Reaction time: the time elapsed between the appearance or activation of a visual stimulus and the initiation of the participant's physical response [ Time Frame: 2 months ]
  • Movement time: the time taken to complete the motor response after it has been initiated. [ Time Frame: 2 months ]
  • Response accuracy: the correctness of the participant's response to each visual stimulus, measured by the number or percentage of correctly identified or responded-to stimuli. [ Time Frame: 2 months ]

Central Contacts and Locations

Central contacts

Locations

Midwestern University Arizona College of Optometry

Recruiting

Glendale, Arizona, United States, 85308

More Information

Sponsor

SightGlass Vision, Inc.

Last update posted

Apr 30, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by SightGlass Vision, Inc. on 2026-04-30.