NCT04388020

Effects of Projected Peripheral Defocus on Ocular Biometrics

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Kubota Vision Inc. · Industry
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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 will stimulate physiological changes similar to those in the literature.

Conditions

• Myopia

Interventions

Type	Name	Description
DEVICE	Tabletop prototype of eSpecs: Active projection of defocused image in the peripheral visual field	For the right/test eye, a defocused image is projected onto the peripheral retina while the subject views a distant, in-focus image
DEVICE	Tabletop prototype of eSpecs: No Active projection of defocused image in the peripheral visual field	For the left/control eye, no image is projected onto the peripheral retina. The subject views a distant, in-focus image.

Timeline

• Start date: 2020-04-11
• Primary completion: 2020-05-14
• Completion: 2020-05-14
• First posted: 2020-05-14
• Last updated: 2021-05-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study