Effects of Projected Peripheral Defocus on Ocular Biometrics

Kubota Vision

Status: Completed

Conditions: Myopia

Treatments: Device: Tabletop prototype of eSpecs: Active projection of defocused image in the peripheral visual field; Device: Tabletop prototype of eSpecs: No Active projection of defocused image in the peripheral visual field

Study type: Interventional

Funder types: Industry

Identifiers

NCT04388020

eSpec Phase IIB

Details and patient eligibility

About

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 will stimulate physiological changes similar to those in the literature.

Enrollment: 12 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Test Arm

Experimental group

Treatment:

Device: Tabletop prototype of eSpecs: No Active projection of defocused image in the peripheral visual field

Device: Tabletop prototype of eSpecs: Active projection of defocused image in the peripheral visual field