Efficacy in Controlling Myopia in Young Children Using a Novel Spectacle Lens
SightGlass Vision, Inc.
Summary
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.
Eligibility
- Age range
- 6–8 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Children 6 - 8 years of age (inclusive) at time of informed consent/assent; 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…
Interventions
- DeviceSingle vision, impact-resistant spectacle lenses; Test Arm
Use of single vision, impact-resistant spectacle lenses may reduce the rate of progression of juvenile myopia
- DeviceSingle vision, impact-resistant spectacle lenses; Control Arm
Single vision, impact-resistant spectacle lenses
Locations (14)
- Elsa Pao, ODOakland, California
- Scripps Poway EyecareSan Diego, California
- Pacific Rims OptometrySan Francisco, California
- Paje OptometricSanta Ana, California
- Omega Vision CenterLongwood, Florida
- Marietta Eye ClinicMarietta, Georgia