Juvenile Myopia
Conditions
Keywords
Myopia
Brief summary
Randomized, controlled, multisite, subject- and observer-masked, contralateral clinical trial of 6-month duration to compare two SightGlass Vision Diffusion Optics Technology (DOT) spectacle lens manufacturing processes in reducing the progression of juvenile myopia.
Interventions
DEVICESightGlass Vision DOT Spectacle Lenses
Subjects randomized to test vs control, left eyes and right eyes
Sponsors
SightGlass Vision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 14 Years
Healthy volunteers
Yes
Inclusion criteria
* Children between the ages of 6 and 14 years old (inclusive) with myopia * Best corrected visual acuity by manifest refraction of +0.10 logMAR (20/25 Snellen equivalent) or better in each eye * Difference in spherical equivalent power between the two eyes (anisometropia based on manifest refraction) must be less than or equal to 0.75 D
Exclusion criteria
* Current use of any myopia control treatment such as atropine, multifocal contact lenses, or orthokeratology (NOTE: Prior bilateral usage acceptable as long as treatment stopped at least 6 months before screening visit. Any subject with a history of unilateral myopia control treatment is excluded.) * 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Axial Length Progression From Baseline | 6 months | Change in axial length progression over time between DOT spectacle lenses manufactured by method A versus method B Axial length progression is defined as an axial length elongation that is attributable to myopia. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| DOT Spectacle Lenses Test Single vision, impact-resistant spectacles using SightGlass Vision DOT spectacle lenses, manufacturing method A
SightGlass Vision DOT Spectacle Lenses: Subjects randomized to test vs control, left eyes and right eyes | 43 |
| DOT Spectacle Lenses Test Single vision, impact-resistant spectacles using SightGlass Vision DOT spectacle lenses, manufacturing method A
SightGlass Vision DOT Spectacle Lenses: Subjects randomized to test vs control, left eyes and right eyes | 43 |
| DOT Spectacle Lenses Control Single vision, impact-resistant spectacles using SightGlass Vision DOT spectacle lenses, manufacturing method B
SightGlass Vision DOT Spectacle Lenses: Subjects randomized to test vs control, left eyes and right eyes | 43 |
| DOT Spectacle Lenses Control Single vision, impact-resistant spectacles using SightGlass Vision DOT spectacle lenses, manufacturing method B
SightGlass Vision DOT Spectacle Lenses: Subjects randomized to test vs control, left eyes and right eyes | 43 |
| Total | 172 |
Baseline characteristics
| Characteristic | DOT Spectacle Lenses Test | DOT Spectacle Lenses Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 43 Eyes | 43 Eyes | 86 Eyes |
| Age, Categorical >=65 years | 0 Eyes | 0 Eyes | 0 Eyes |
| Age, Categorical Between 18 and 65 years | 0 Eyes | 0 Eyes | 0 Eyes |
| Age, Continuous | 11.67 years STANDARD_DEVIATION 2.073 | 11.67 years STANDARD_DEVIATION 2.073 | 11.67 years STANDARD_DEVIATION 2.073 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Eyes | 6 Eyes | 12 Eyes |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 37 Eyes | 37 Eyes | 74 Eyes |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Eyes | 0 Eyes | 0 Eyes |
| Race (NIH/OMB) American Indian or Alaska Native | 5 Eyes | 5 Eyes | 10 Eyes |
| Race (NIH/OMB) Asian | 2 Eyes | 2 Eyes | 4 Eyes |
| Race (NIH/OMB) Black or African American | 9 Eyes | 9 Eyes | 18 Eyes |
| Race (NIH/OMB) More than one race | 0 Eyes | 0 Eyes | 0 Eyes |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Eyes | 0 Eyes | 0 Eyes |
| Race (NIH/OMB) Unknown or Not Reported | 0 Eyes | 0 Eyes | 0 Eyes |
| Race (NIH/OMB) White | 27 Eyes | 27 Eyes | 54 Eyes |
| Region of Enrollment United States | 43 Eyes | 43 Eyes | 86 Eyes |
| Sex: Female, Male Female | 21 Eyes | 21 Eyes | 42 Eyes |
| Sex: Female, Male Male | 22 Eyes | 22 Eyes | 44 Eyes |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 43 | 0 / 43 |
| other Total, other adverse events | 0 / 43 | 0 / 43 |
| serious Total, serious adverse events | 0 / 43 | 0 / 43 |
Outcome results
Primary
Change in Axial Length Progression From Baseline
Change in axial length progression over time between DOT spectacle lenses manufactured by method A versus method B Axial length progression is defined as an axial length elongation that is attributable to myopia.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DOT Spectacle Lenses Using Test | Change in Axial Length Progression From Baseline | 0.046 mm | Standard Deviation 0.139 |
| DOT Spectacle Lenses Using Control | Change in Axial Length Progression From Baseline | 0.047 mm | Standard Deviation 0.128 |