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Projected Peripheral Defocus Using a Wearable Device

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active projection of defocused image in the peripheral visual field (eSpecs, Acucela Inc.)
No Active projection of defocused image in the peripheral visual field (eSpecs, Acucela Inc.)
Sponsored by
Kubota Vision Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Manhattan Vision Associates/institute of Vision Research

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Test Arm

Arm Description

Outcomes

Primary Outcome Measures

Axial length (AL)
Change in AL from baseline in the test eye vs. control eye
Choroidal thickness (CT)
Change in CT from baseline in the test eye vs. control eye

Secondary Outcome Measures

Full Information

First Posted
June 1, 2020
Last Updated
August 16, 2021
Sponsor
Kubota Vision Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04415684
Brief Title
Projected Peripheral Defocus Using a Wearable Device
Official Title
Effects of Projected Peripheral Defocus on Ocular Biometrics Using a Wearable Device
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
June 29, 2020 (Actual)
Primary Completion Date
August 20, 2020 (Actual)
Study Completion Date
August 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kubota Vision Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test Arm
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Active projection of defocused image in the peripheral visual field (eSpecs, Acucela Inc.)
Intervention Description
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
Intervention Name(s)
No Active projection of defocused image in the peripheral visual field (eSpecs, Acucela Inc.)
Intervention Description
For the left/control eye, no image is projected onto the peripheral retina. The subject views a distant, in-focus image.
Primary Outcome Measure Information:
Title
Axial length (AL)
Description
Change in AL from baseline in the test eye vs. control eye
Time Frame
1 hour
Title
Choroidal thickness (CT)
Description
Change in CT from baseline in the test eye vs. control eye
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arkady Selenow, OD
Organizational Affiliation
Manhattan Vision Associates/Institute of Vision Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Manhattan Vision Associates/institute of Vision Research
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Projected Peripheral Defocus Using a Wearable Device

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