Effect of Diffusion Optics Technology (DOT) Spectacle Lenses on Choroidal Thickness

NCT ID: NCT05617794

Last Updated: 2024-12-20

Study Results

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-18

Study Completion Date

2026-03-31

Brief Summary

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The objective of the study is to measure the effect of Diffusion Optics Technology (DOT) spectacle lenses on the choroidal thickness and choroidal vascularity index compared to control lenses.

Detailed Description

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Conditions

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Myopia Myopia Progression Juvenile Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Treatment 1 - Diffusion Optics Technology (DOT) Pattern

Group Type EXPERIMENTAL

Diffusion Optics Technology (DOT) Pattern Spectacle Lens

Intervention Type DEVICE

DOT Pattern Spectacle Lens

Treatment 2 - Control Spectacles

Group Type ACTIVE_COMPARATOR

Control Spectacle Lens

Intervention Type DEVICE

Control Spectacles

Interventions

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Diffusion Optics Technology (DOT) Pattern Spectacle Lens

DOT Pattern Spectacle Lens

Intervention Type DEVICE

Control Spectacle Lens

Control Spectacles

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Are 8-14 years of age;
* 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

* Are participating in any concurrent interventional clinical or research study;
* 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.
Minimum Eligible Age

8 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Waterloo

OTHER

Sponsor Role collaborator

SightGlass Vision, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre for Ocular Research and Education

Waterloo, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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CPRO-2207-001

Identifier Type: -

Identifier Source: org_study_id