Actively Recruiting
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
Eligibility Criteria
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
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
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
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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