N/A N=100 Randomized Treatment

Myopia Assessment of Two Manufacturing Processes

Juvenile Myopia

Bottom Line

View on ClinicalTrials.gov: NCT04126057 ↗

Enrolled (actual)

100

Serious AEs

0.0%

Results posted

Jan 2022

Primary outcome: Primary: Change in Axial Length Progression From Baseline — 0.046; 0.047 mm

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: SightGlass Vision DOT Spectacle Lenses (Device)
Age: Pediatric · 6+ yrs
Sex: All
Sponsor: SightGlass Vision, Inc.
Primary completion: Sep 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Axial Length Progression From Baseline	0.046; 0.047	—

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.

Eligibility Criteria

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04126057). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.