Projected Peripheral Defocus Using a Wearable Device

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04415684
• Other study ID #: eSpec Phase III
• Status: Completed
• Phase: N/A
• Start date: June 29, 2020
• Est. completion date: August 20, 2020

Study information

• Verified date: August 2021
• Source: Kubota Vision Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: August 20, 2020
• Est. primary completion date: August 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Myopia

Intervention

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
• 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.

Locations

Country	Name	City	State
United States	Manhattan Vision Associates/institute of Vision Research	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Kubota Vision Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Axial length (AL)	Change in AL from baseline in the test eye vs. control eye	1 hour
Primary	Choroidal thickness (CT)	Change in CT from baseline in the test eye vs. control eye	1 hour