Lag of Accommodation With DOT Spectacle Lenses

NCT ID: NCT04700111

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

2022-02-01

Study Completion Date

2026-03-31

Brief Summary

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The objective of the study is to measure the difference in the lag of accommodation between DOT spectacle lenses and control spectacles.

Detailed Description

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Conditions

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Myopia, Myopia Progression, Lag of Accommodation, Hyperopic Retinal Blur, Reduction in Contrast

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 - DOT Pattern

Spectacle lens or treatment 1

Group Type EXPERIMENTAL

DOT Pattern

Intervention Type DEVICE

DOT Pattern Spectacle Lens

Treatment 2 - Control Spectacles

Comparator lens or control arm

Group Type ACTIVE_COMPARATOR

Control Spectacles

Intervention Type DEVICE

Control lens

Interventions

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DOT Pattern

DOT Pattern Spectacle Lens

Intervention Type DEVICE

Control Spectacles

Control lens

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Age 6-18 years of age, with a maximum of 6 of the first 25 completed participants being older than 14 years of age.
2. Is able to read (or be read to), understand and sign the assent document if under 17 years old or is able to read, understand and sign the consent document if aged 17 or 18 years.
3. Is under 17 years old and is accompanied by a parent or legal guardian who is able to read, understand and sign the parental information and permission document.
4. Should be emmetropic by non-cycloplegic auto-refraction, which means both refractive meridians should be within +1.00D and -1.00D.
5. Is willing and able to follow instructions.

A person will be excluded from the study if he/she:

1. Is participating in any concurrent clinical or research study.
2. Have a history of myopia control treatment in the past year.
3. Has amblyopia in either eye or known to have any other binocular vision disorder, such as accommodative insufficiency.
4. Has any known active ocular disease and/or infection.
5. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable. Examples include diabetes mellitus, hyperthyroidism.
6. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable. Examples include Atropine eye drops.
7. Has undergone strabismus surgery, refractive error surgery or intraocular surgery.
8. Is a child of a member of the study team.
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 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-2011-001

Identifier Type: -

Identifier Source: org_study_id