Myopia
Conditions
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.
Interventions
DEVICEActive 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
DEVICENo 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.
Sponsors
Kubota Vision Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed