Juvenile Myopia
Conditions
Keywords
Myopia
Brief summary
Randomized, controlled, multisite, subject-and observer-masked, 3-arm parallel group clinical trial of 36-month duration to evaluate the safety and efficacy of a novel spectacle lens design in reducing the progression of juvenile myopia.
Interventions
Use of lenses may reduce the rate of progression of juvenile myopia
DEVICESpectacle lenses
Use of lenses may reduce the rate of progression of juvenile myopia
Sponsors
SightGlass Vision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants and parents of participants will be masked. Investigational site staff tasked with measuring key primary variables (i.e., axial length and SER) will be masked.
Eligibility
Sex/Gender
ALL
Age
6 Years to 10 Years
Healthy volunteers
Yes
Inclusion criteria
* Children 6-10 years of age (day prior to 10th birthday) at time of informed consent/assent * SER error between -0.75 and -4.50 D * SER power between the two eyes must be less than or equal to 1.50 D * Willingness to participate in the trial for 3 years without content lens wear
Exclusion criteria
* Previous or current use of contact lenses * Previous or current use of bifocals, progressive addition spectacles lenses * Previous or current use of myopia control treatment * Astigmatism worse then -1.25 DC in either eye
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Axial length | 36 Months | Change in axial length from baseline |
| Spherical equivalent refraction | 36 Months | Change in spherical equivalent refraction from baseline |
Countries
Canada, United States
Contacts
STUDY_CHAIRJoseph Rappon, OD, MS, FAAO
SightGlass Vision, Inc.
Outcome results
None listed