Effect of Diffusion Optics Technology (DOT) Spectacle Lenses on Choroidal Thickness
NCT ID: NCT05617794
Last Updated: 2024-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
30 participants
INTERVENTIONAL
2023-01-18
2026-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Treatment 1 - Diffusion Optics Technology (DOT) Pattern
Diffusion Optics Technology (DOT) Pattern Spectacle Lens
DOT Pattern Spectacle Lens
Treatment 2 - Control Spectacles
Control Spectacle Lens
Control Spectacles
Interventions
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Diffusion Optics Technology (DOT) Pattern Spectacle Lens
DOT Pattern Spectacle Lens
Control Spectacle Lens
Control Spectacles
Eligibility Criteria
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Inclusion Criteria
* Are able to read (or be read to), understand and sign the assent document;
* Are accompanied by a parent or legal guardian who is able to read, understand and sign the parental information and permission document;
* Are emmetropic by non-cycloplegic auto-refraction, which means both refractive meridians should be within +1.00D and -1.00D inclusively;
* Are willing and able to follow instructions.
Exclusion Criteria
* Have a history of myopia control treatment in the past year;
* Have amblyopia in either eye or known to have any other binocular vision disorder, such as accommodative insufficiency;
* Have any known active ocular disease and/or infection;
* Have a systemic condition that in the opinion of the investigator may affect a study outcome variable. Examples include diabetes mellitus, hyperthyroidism;
* Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable. Examples include Atropine eye drops;
* Have undergone strabismus surgery, refractive error surgery or intraocular surgery;
* Are a child of a member of the study team.
8 Years
14 Years
ALL
Yes
Sponsors
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University of Waterloo
OTHER
SightGlass Vision, Inc.
INDUSTRY
Responsible Party
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Locations
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Centre for Ocular Research and Education
Waterloo, Ontario, Canada
Countries
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Other Identifiers
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CPRO-2207-001
Identifier Type: -
Identifier Source: org_study_id