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Projected Peripheral Defocus Using a Wearable Device

NCT04415684 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2021-08-20

No results posted yet for this study

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.

Conditions

  • Myopia

Interventions

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.

Sponsors & Collaborators

  • Kubota Vision Inc.

    lead INDUSTRY

Principal Investigators

  • Arkady Selenow, OD · Manhattan Vision Associates/Institute of Vision Research

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-29
Primary Completion
2020-08-20
Completion
2020-08-20
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04415684 on ClinicalTrials.gov