Projected Peripheral Defocus Using a Wearable Device

Effects of Projected Peripheral Defocus on Ocular Biometrics Using a Wearable Device

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.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: 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.)

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10022
      • Manhattan Vision Associates/institute of Vision Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Axial length (AL)	Change in AL from baseline in the test eye vs. control eye	1 hour
Choroidal thickness (CT)	Change in CT from baseline in the test eye vs. control eye	1 hour

Collaborators and Investigators

• Sponsor: Kubota Vision Inc.
• Investigators: Principal Investigator: Arkady Selenow, OD, Manhattan Vision Associates/institute of Vision Research

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2020
• Primary Completion (Actual): August 20, 2020
• Study Completion (Actual): August 20, 2020

Study Registration Dates

• First Submitted: June 1, 2020
• First Submitted That Met QC Criteria: June 3, 2020
• First Posted (Actual): June 4, 2020

Study Record Updates

• Last Update Posted (Actual): August 20, 2021
• Last Update Submitted That Met QC Criteria: August 16, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: eSpec Phase III

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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