Actively Recruiting

Phase Not Applicable
Age: 6Years - 8Years
All Genders
Healthy Volunteers
NCT06034327

Efficacy in Controlling Myopia in Young Children Using a Novel Spectacle Lens

Led by SightGlass Vision, Inc. · Updated on 2025-12-29

150

Participants Needed

14

Research Sites

184 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a conventional efficacy trial to validate the results from previous clinical trials for younger children; the 12-month efficacy results will be used to predict the 3-year treatment efficacy. This is a randomized, controlled (1:1), multisite, subject- and observer-masked, 2-arm parallel group study.

CONDITIONS

Official Title

Efficacy in Controlling Myopia in Young Children Using a Novel Spectacle Lens

Who Can Participate

Age: 6Years - 8Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 6 to 8 years at time of consent
  • Spherical equivalent refractive error between -0.75 and -4.50 diopters in each eye
  • Astigmatism of -1.25 diopters or less in each eye
  • Best corrected visual acuity of +0.10 logMAR (20/25 Snellen) or better in each eye
  • Difference in spherical equivalent power between eyes of 1.50 diopters or less
  • Agree to wear assigned spectacles at least 10 hours per day except when sleeping, swimming, or during unsafe activities
  • Ability to comply with study procedures including various eye measurements at baseline
  • Willingness to participate for 24 months without wearing contact lenses
  • Parent or legal guardian must understand and sign informed consent
Not Eligible

You will not qualify if you...

  • Previous or current contact lens use for more than one month
  • Current or prior use of bifocals or progressive addition lenses
  • Prior use of any myopia control treatment such as atropine, multifocal contact lenses, or orthokeratology
  • Amblyopia in either eye
  • Strabismus detected by cover test at far or near distances while wearing correction
  • Any ocular or systemic condition affecting eye development or vision including keratoconus, congenital glaucoma, ocular trauma, diabetes, Marfan syndrome, connective tissue disorders, Down's syndrome, or family history of congenital stationary night blindness
  • Known allergy to proparacaine, tetracaine, or tropicamide
  • Participation in another clinical trial within 30 days before baseline
  • A sibling or household member already enrolled in this trial

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 14 locations

1

Elsa Pao, OD

Oakland, California, United States, 94607

Actively Recruiting

2

Scripps Poway Eyecare

San Diego, California, United States, 92131

Actively Recruiting

3

Pacific Rims Optometry

San Francisco, California, United States, 94127

Actively Recruiting

4

Paje Optometric

Santa Ana, California, United States, 92704

Actively Recruiting

5

Omega Vision Center

Longwood, Florida, United States, 32779

Actively Recruiting

6

Marietta Eye Clinic

Marietta, Georgia, United States, 30060

Actively Recruiting

7

Ilinois College of Optometry

Chicago, Illinois, United States, 60616

Actively Recruiting

8

Kannarr Eye Care

Pittsburg, Kansas, United States, 66762

Actively Recruiting

9

New England College of Optometry

Boston, Massachusetts, United States, 02115

Actively Recruiting

10

Advanced Eyecare PC

Raytown, Missouri, United States, 64133

Actively Recruiting

11

Athens Eye Care

Athens, Ohio, United States, 45701

Actively Recruiting

12

Procare Vision Centers, Inc.

Granville, Ohio, United States, 43023

Actively Recruiting

13

Texas State Optical - Dowlen

Beaumont, Texas, United States, 77706

Actively Recruiting

14

Bellaire Family Eye Care

Bellaire, Texas, United States, 77401

Actively Recruiting

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Research Team

J

Jennifer S Hill, BS

CONTACT

V

Vanessa Tasso, MA, MBA

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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