Effects of Projected Peripheral Defocus on Ocular Biometrics

K

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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