Back to resultsEffects of Projected Peripheral Defocus on Ocular Biometrics
Primary Purpose
Myopia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tabletop prototype of eSpecs: Active projection of defocused image in the peripheral visual field
Tabletop prototype of eSpecs: No Active projection of defocused image in the peripheral visual field
Sponsored by
About this trial
This is an interventional treatment trial for Myopia
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
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
1. Study Identification
Unique Protocol Identification Number
NCT04388020
Brief Title
Effects of Projected Peripheral Defocus on Ocular Biometrics
Official Title
Effects of Projected Peripheral Defocus on Ocular Biometrics
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
April 11, 2020 (Actual)
Primary Completion Date
May 14, 2020 (Actual)
Study Completion Date
May 14, 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
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 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
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test Arm
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Tabletop prototype of eSpecs: Active projection of defocused image in the peripheral visual field
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)
Tabletop prototype of eSpecs: No Active projection of defocused image in the peripheral visual field
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
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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Effects of Projected Peripheral Defocus on Ocular Biometrics
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