Tolerability of a Novel Spectacle Design With Reduced Peripheral Contrast
Not Applicable
Completed
- Conditions
- Myopia
- Interventions
- Device: Spectacle lenses
- Registration Number
- NCT03761758
- Lead Sponsor
- SightGlass Vision, Inc.
- Brief Summary
Prospective, randomized, subject-masked 3-arm clinical study to assess the pediatric acceptability across three iterations of a novel spectacle lens design.
- Detailed Description
This feasibility study was conducted to assess the performance of three experimental spectacle lens designs (spectacle lenses) in children between 6 and 9 years of age with myopia.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 21
Inclusion Criteria
- Ages between 6 and 12 years
- Myopia between -1.00 and -4.00 D
Exclusion Criteria
- Participating in any clinical or other research study
- Contact lens wearer
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lens Design 3 Spectacle lenses Spectacle lenses design 3, fitted into spectacle frames Lens Design 1 Spectacle lenses Spectacle lenses design 1, fitted into spectacle frames Lens Design 2 Spectacle lenses Spectacle lenses design 2, fitted into spectacle frames
- Primary Outcome Measures
Name Time Method Distance Visual Acuity 2 weeks Measurement of best corrected distance visual acuity
Subjective Responses 2 weeks Assessment of subject responses related to wear time of spectacles
Contrast Sensitivity 2 weeks Measurement of contrast sensitivity
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Centre for Ocular Research & Education
🇨🇦Waterloo, Ontario, Canada