Projected Peripheral Defocus Using a Wearable Device

NCT ID: NCT04415684

Last Updated: 2021-08-20

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

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-29

Study Completion Date

2020-08-20

Brief Summary

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Acucela Inc. intends to develop a medical device to significantly halt or reverse myopic progression, which is a significant public health concern across the world, especially in Asian demographics. Acucela is working towards a spectacle-like device (eSPECs), which will have a clear zone for unimpeded central visual tasks and a periphery that provides defocus in order to alter retinal physiology leading to myopia regulation. This study will establish the changes seen during a proof-of-concept that projected defocus in the periphery utilizing a wearable device will stimulate physiological changes similar to those in the literature.

Detailed Description

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Conditions

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Myopia

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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Test Arm

Group Type EXPERIMENTAL

Active projection of defocused image in the peripheral visual field (eSpecs, Acucela Inc.)

Intervention Type DEVICE

For the right/test eye, a defocused image is projected onto the peripheral retina while the subject views a distant, in-focus image

No Active projection of defocused image in the peripheral visual field (eSpecs, Acucela Inc.)

Intervention Type DEVICE

For the left/control eye, no image is projected onto the peripheral retina. The subject views a distant, in-focus image.

Interventions

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Active projection of defocused image in the peripheral visual field (eSpecs, Acucela Inc.)

For the right/test eye, a defocused image is projected onto the peripheral retina while the subject views a distant, in-focus image

Intervention Type DEVICE

No Active projection of defocused image in the peripheral visual field (eSpecs, Acucela Inc.)

For the left/control eye, no image is projected onto the peripheral retina. The subject views a distant, in-focus image.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Spherical equivalent +2.00 to -4.00 diopters
* Refractive cylinder ≤ 0.75 diopters
* Visual acuity 20/20 -3 or better

Exclusion Criteria

* Pregnant or lactating
* Active ocular infection
* History of dry eye, strabismus, or amblyopia
* Previous or planned ocular surgery
* Use of medication known to affect vision or accommodation
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

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

Countries

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United States

Other Identifiers

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eSpec Phase III

Identifier Type: -

Identifier Source: org_study_id

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