Binocular Peripheral Myopic Defocus Using a Clinical Prototype Device

NCT ID: NCT05425108

Last Updated: 2022-07-06

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-23

Study Completion Date

2023-08-31

Brief Summary

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Kubota Vision Inc. has developed a spectacle-like prototype device which is designed to be used as a light-based therapy to reduce myopia progression. In this study, we aim to observe the ocular biometric and refractive changes following binocular part-time wear of the clinical prototype device over a course of 12 months and compare that to 12 months of no clinical prototype device use (control).

Detailed Description

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Conditions

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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CP1 device

Group Type ACTIVE_COMPARATOR

Binocular CP1

Intervention Type DEVICE

Binocular active projection of defocused image in the peripheral visual field

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Binocular CP1

Binocular active projection of defocused image in the peripheral visual field

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Spherical equivalent -0.50 to -5.50 diopters
* visual acuity of at least 20/25 in each eye

Exclusion Criteria

* history of ocular trauma or major eye surgery
* active ocular infection
* any prior history or participation in myopia control treatments within the past 3 months
Minimum Eligible Age

7 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kubota Vision Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Arkady Selenow, OD

Role: PRINCIPAL_INVESTIGATOR

Manhattan Vision Associates/Institute of Vision Research

Locations

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Manhattan Vision Associates/Institute of Vision Research

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Clinical Trials Helpdesk

Role: CONTACT

(206) 805-8310

Facility Contacts

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Study Coordinator

Role: primary

212-688-4277

Other Identifiers

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CP1 Pilot

Identifier Type: -

Identifier Source: org_study_id

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