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Choroidal Response to Novel Spectacle Lens to Control Myopia Progression

NCT ID: NCT03818880

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

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-18

Study Completion Date

2026-03-31

Brief Summary

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Diurnal variations in the thickness of the choroid have been reported in the literature, and, more recently, the role of the choroid has been studied with respect to its role in myopia (near-sightedness) progression.

Detailed Description

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Diurnal variations in the thickness of the choroid have been reported in the literature , and, more recently, the role of the choroid has been studied with respect to its role in myopia (near-sightedness) progression. SightGlass Vision, Inc is conducting a multi-site, randomized, controlled, interventional study to confirm the efficacy and safety of spectacle lenses designed to inhibit the progression of myopia by reducing image contrast in peripheral vision. CORE is participating as a clinical site in this three year study which aims to compare changes in ocular length and cycloplegic auto-refraction in children randomised to wear one of either two test or one control spectacle lens designs; the CPRO-1802-001 (Cypress\_SG) study. The sponsor is interested in conducting choroidal thickness measurements only at CORE's site by inviting those participants who have already been found eligible for the CPRO-1802-001 study to participate in this parallel study.

Conditions

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Myopia, Progressive

Keywords

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Myopia Myopia control

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

Subjects wearing novel spectacle lenses will be assessed

Group Type EXPERIMENTAL

Novel spectacle lens design

Intervention Type DEVICE

Spectacle lens to control progression of myopia

Interventions

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Novel spectacle lens design

Spectacle lens to control progression of myopia

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Participating in the CPRO-1802-001 (Cypress\_SG) study at CORE
* Read and signed an Assent and their parent/guardian has signed an information consent letter

Exclusion Criteria

* Transient health condition which may affect the eye(s) (e.g. a common cold, active allergies, fatigue, etc;)
Minimum Eligible Age

6 Years

Maximum Eligible Age

10 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

Principal Investigators

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Lyndon Jones, PhD, FCOptom

Role: PRINCIPAL_INVESTIGATOR

Centre for Ocular Research & Education, Canada

Jill Woods, BSc, MCOptom

Role: STUDY_DIRECTOR

Centre for Ocular Research & Education, Canada

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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P/654/18/SG

Identifier Type: -

Identifier Source: org_study_id