Projected Peripheral Defocus Using a Wearable Device

Not Applicable

Completed

• Conditions: Myopia
• Interventions: 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.)

• Registration Number: NCT04415684
• Lead Sponsor: Kubota Vision Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-01
• Study First Submitted QC: 2020-06-03
• Study First Posted: 2020-06-04
• Study Start: 2020-06-29
• Primary Completion: 2020-08-20
• Study Completion: 2020-08-20
• Status Verified: 2021-08
• Disposition First Submitted: 2021-08-16
• Disposition First Submitted QC: 2021-08-16
• Last Update Submitted: 2021-08-16
• Disposition First Posted: 2021-08-20
• Last Update Posted: 2021-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Test Arm	Active projection of defocused image in the peripheral visual field (eSpecs, Acucela Inc.)	-
Test Arm	No Active projection of defocused image in the peripheral visual field (eSpecs, Acucela Inc.)	-

Primary Outcome Measures

Name	Time	Method
Choroidal thickness (CT)	1 hour	Change in CT from baseline in the test eye vs. control eye
Axial length (AL)	1 hour	Change in AL from baseline in the test eye vs. control eye

Trial Locations

Locations (1)

Manhattan Vision Associates/institute of Vision Research; 🇺🇸 New York, New York, United States