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Projected Peripheral Defocus Using a Wearable Device

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04415684
Recruitment Status : Completed
First Posted : June 4, 2020
Last Update Posted : August 27, 2020
Sponsor:
Information provided by (Responsible Party):
Kubota Vision Inc.

Tracking Information
First Submitted Date  ICMJE June 1, 2020
First Posted Date  ICMJE June 4, 2020
Last Update Posted Date August 27, 2020
Actual Study Start Date  ICMJE June 29, 2020
Actual Primary Completion Date August 20, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 26, 2020)
  • Axial length (AL) [ Time Frame: 1 hour ]
    Change in AL from baseline in the test eye vs. control eye
  • Choroidal thickness (CT) [ Time Frame: 1 hour ]
    Change in CT from baseline in the test eye vs. control eye
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Projected Peripheral Defocus Using a Wearable Device
Official Title  ICMJE Effects of Projected Peripheral Defocus on Ocular Biometrics Using a Wearable Device
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Myopia
Intervention  ICMJE
  • Device: 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
  • 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.
Study Arms  ICMJE Experimental: Test Arm
Interventions:
  • Device: Active projection of defocused image in the peripheral visual field (eSpecs, Acucela Inc.)
  • Device: No Active projection of defocused image in the peripheral visual field (eSpecs, Acucela Inc.)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 26, 2020)
26
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE August 20, 2020
Actual Primary Completion Date August 20, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04415684
Other Study ID Numbers  ICMJE eSpec Phase III
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Kubota Vision Inc.
Study Sponsor  ICMJE Kubota Vision Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Arkady Selenow, OD Manhattan Vision Associates/Institute of Vision Research
PRS Account Kubota Vision Inc.
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP