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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.

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.

Condition or disease Intervention/treatment Phase
Myopia 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.) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Projected Peripheral Defocus on Ocular Biometrics Using a Wearable Device
Actual Study Start Date : June 29, 2020
Actual Primary Completion Date : August 20, 2020
Actual Study Completion Date : August 20, 2020

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Arm Intervention/treatment
Experimental: Test Arm 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.




Primary Outcome Measures :
  1. Axial length (AL) [ Time Frame: 1 hour ]
    Change in AL from baseline in the test eye vs. control eye

  2. Choroidal thickness (CT) [ Time Frame: 1 hour ]
    Change in CT from baseline in the test eye vs. control eye



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04415684


Locations
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United States, New York
Manhattan Vision Associates/institute of Vision Research
New York, New York, United States, 10022
Sponsors and Collaborators
Kubota Vision Inc.
Investigators
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Principal Investigator: Arkady Selenow, OD Manhattan Vision Associates/Institute of Vision Research
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Responsible Party: Kubota Vision Inc.
ClinicalTrials.gov Identifier: NCT04415684    
Other Study ID Numbers: eSpec Phase III
First Posted: June 4, 2020    Key Record Dates
Last Update Posted: August 27, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Myopia
Refractive Errors
Eye Diseases