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OpenTrials
Completed

NCT Number: NCT04415684

Projected Peripheral Defocus 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.

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Manhattan Vision Associates/institute of Vision Research

New York, 10022, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active projection of defocused image in the peripheral visual field (eSpecs, Acucela Inc.)

Device

For the right/test eye, a defocused image is projected onto the peripheral retina while the subject views a distant, in-focus image

No Active projection of defocused image in the peripheral visual field (eSpecs, Acucela Inc.)

Device

For the left/control eye, no image is projected onto the peripheral retina. The subject views a distant, in-focus image.

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Kubota Vision Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 4, 2020
Registry last updated
Aug 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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