Projected Peripheral Defocus Using a Wearable Device

• Sponsor: Kubota Vision Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04415684
• Collaborator: (none)
• Enrollment: 26
• Location: 1
• Arm: 1
• Actual Duration (Months): 1.7
• Patients Per Site Per Month: 15.2

Study Details

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.

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.)	N/A

Study Design

• Study Type: Interventional
• 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: Jun 29, 2020
• Actual Primary Completion Date: Aug 20, 2020
• Actual Study Completion Date: Aug 20, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Axial length (AL) [1 hour]

   Change in AL from baseline in the test eye vs. control eye

2. Choroidal thickness (CT) [1 hour]

   Change in CT from baseline in the test eye vs. control eye

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Manhattan Vision Associates/institute of Vision Research	New York	New York	United States	10022

Sponsors and Collaborators

• Kubota Vision Inc.

Investigators

• Principal Investigator: Arkady Selenow, OD, Manhattan Vision Associates/Institute of Vision Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kubota Vision Inc.
• ClinicalTrials.gov Identifier: NCT04415684
• Other Study ID Numbers: eSpec Phase III
• First Posted: Jun 4, 2020
• Last Update Posted: Aug 20, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Myopia

Study Results

No Results Posted as of Aug 20, 2021