Effects of Projected Peripheral Defocus on Ocular Biometrics

NCT04388020 | Completed FDA Device

• 1 other identifier: eSpec Phase IIB
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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 will stimulate physiological changes similar to those in the literature.

Conditions

Myopia

Outcome Measures

Primary Outcomes (2)

• Axial length (AL)

  Change in AL from baseline in the test eye vs. control eye

  1 hour

• Choroidal thickness (CT)

  Change in CT from baseline in the test eye vs. control eye

  1 hour

Study Arms (1)

Test Arm

EXPERIMENTAL

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

Interventions

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

For the right/test eye, a defocused image is projected onto the peripheral retina while the subject views a distant, in-focus image

Test Arm

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

For the left/control eye, no image is projected onto the peripheral retina. The subject views a distant, in-focus image.

Test Arm

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Spherical equivalent +2.00 to -4.00 diopters
• Refractive cylinder ≤ 0.75 diopters
• Visual acuity 20/20 -3 or better

You may not qualify if:

• 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

Sponsors & Collaborators

• Kubota Vision Inc.: lead

Study Sites (1)

Manhattan Vision Associates/institute of Vision Research

New York, New York, 10022, United States

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Arkady Selenow, OD

  Manhattan Vision Associates

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2020
• First Posted: May 14, 2020
• Study Start: April 11, 2020
• Primary Completion: May 14, 2020
• Study Completion: May 14, 2020
• Last Updated: May 21, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)