Efficacy in Controlling Myopia in Young Children Using a Novel Spectacle Lens
NCT ID: NCT06034327
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
150 participants
INTERVENTIONAL
2023-09-18
2027-03-31
Brief Summary
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This is a randomized, controlled (1:1), multisite, subject- and observer-masked, 2-arm parallel group study.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Test Arm 1
Single vision, impact-resistant spectacle lenses
Single vision, impact-resistant spectacle lenses; Test Arm
Use of single vision, impact-resistant spectacle lenses may reduce the rate of progression of juvenile myopia
Test Arm 2
Single vision, impact-resistant spectacle lenses
Single vision, impact-resistant spectacle lenses; Control Arm
Single vision, impact-resistant spectacle lenses
Interventions
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Single vision, impact-resistant spectacle lenses; Test Arm
Use of single vision, impact-resistant spectacle lenses may reduce the rate of progression of juvenile myopia
Single vision, impact-resistant spectacle lenses; Control Arm
Single vision, impact-resistant spectacle lenses
Eligibility Criteria
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Inclusion Criteria
2. Spherical equivalent refractive error between -0.75 and -4.50 D inclusive (by manifest refraction) in each eye;
3. Astigmatism if present, less than or equal to -1.25 DC (by manifest refraction) in each eye;
4. Best corrected visual acuity by manifest refraction of +0.10 logMAR (20/25 Snellen equivalent) or better in each eye;
5. The difference in spherical equivalent power between the two eyes (anisometropia based on manifest refraction) must be less than or equal to 1.50 D;
6. Agree to wear the assigned spectacles constantly except for sleeping, swimming, or other activities in which spectacle wear would be dangerous or otherwise not possible (minimum of 10 hours per day);
7. Ability to comply with study procedures, including high and low contrast visual acuity, axial length, and cycloplegic autorefraction measurements taken for both eyes at the baseline visit;
8. Willingness to participate in the trial for 24 months without contact lens wear;
9. 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
2. Current or prior use of bifocals, progressive addition spectacle lenses
3. Current or prior use of any myopia control treatment (e.g., atropine, multifocal contact lenses, orthokeratology);
4. Amblyopia in either eye;
5. Strabismus by cover test at far (4 m) or near (40 cm) wearing distance correction;
6. Any ocular or systemic conditions that could influence refractive development or status \[e.g., keratoconus, congenital glaucoma, ocular trauma, diabetes, Marfan syndrome or other connective tissue disorder, Down's syndrome, family history of poor night vision (to prevent against enrolling subjects with congenital stationary night blindness)\];
7. Known allergy to proparacaine, tetracaine, or tropicamide;
8. Participation in any investigational clinical study within 30 days of the Baseline visit;
9. Subject's sibling or other household member is already enrolled in this trial.
6 Years
8 Years
ALL
Yes
Sponsors
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SightGlass Vision, Inc.
INDUSTRY
Responsible Party
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Locations
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Elsa Pao, OD
Oakland, California, United States
Scripps Poway Eyecare
San Diego, California, United States
Pacific Rims Optometry
San Francisco, California, United States
Paje Optometric
Santa Ana, California, United States
Omega Vision Center
Longwood, Florida, United States
Marietta Eye Clinic
Marietta, Georgia, United States
Ilinois College of Optometry
Chicago, Illinois, United States
Kannarr Eye Care
Pittsburg, Kansas, United States
New England College of Optometry
Boston, Massachusetts, United States
Advanced Eyecare PC
Raytown, Missouri, United States
Athens Eye Care
Athens, Ohio, United States
Procare Vision Centers, Inc.
Granville, Ohio, United States
Texas State Optical - Dowlen
Beaumont, Texas, United States
Bellaire Family Eye Care
Bellaire, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Vanessa Chen
Role: primary
Leslie Shan, OD
Role: primary
Aileen Guzman
Role: primary
Daisy Magdaleno
Role: primary
Renee Warren
Role: primary
Doreatha Kennerly
Role: primary
Jessica Martinez
Role: primary
Megan Compton, RN
Role: primary
Lilly Cheam
Role: primary
Tamara Urias
Role: primary
Jen Brite
Role: primary
Shane Foster, OD
Role: backup
Katherine Bickle, OD
Role: primary
Bobbie Hampton
Role: primary
Ashley Tucker, OD
Role: primary
Other Identifiers
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CPRO-2304-001
Identifier Type: -
Identifier Source: org_study_id
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