Status:
COMPLETED
Myopia Assessment of Two Manufacturing Processes
Lead Sponsor:
SightGlass Vision, Inc.
Conditions:
Juvenile Myopia
Eligibility:
All Genders
6-14 years
Phase:
NA
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 manu...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
December 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 16 2020
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04126057
Start Date
December 2 2019
End Date
September 16 2020
Last Update
January 25 2022
Active Locations (5)
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1
Sabal Eye Care
Longwood, Florida, United States, 32779
2
Kannarr Eye Care
Pittsburg, Kansas, United States, 66762
3
Advanced Eyecare PC
Raytown, Missouri, United States, 64133
4
SUNY School of Optometry
New York, New York, United States, 10036