Effects of Projected Peripheral Defocus on Ocular Biometrics

Not Applicable

Completed

• Conditions: Myopia

• Registration Number: NCT04388020
• Lead Sponsor: Kubota Vision Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-11
• Study First Submitted: 2020-05-07
• Study First Submitted QC: 2020-05-11
• Primary Completion: 2020-05-14
• Study Completion: 2020-05-14
• Study First Posted: 2020-05-14
• Status Verified: 2021-05
• Disposition First Submitted: 2021-05-10
• Disposition First Submitted QC: 2021-05-15
• Last Update Submitted: 2021-05-15
• Disposition First Posted: 2021-05-21
• Last Update Posted: 2021-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Axial length (AL)	1 hour	Change in AL from baseline in the test eye vs. control eye
Choroidal thickness (CT)	1 hour	Change in CT from baseline in the test eye vs. control eye

Trial Locations

Locations (1)

Manhattan Vision Associates/institute of Vision Research; 🇺🇸 New York, New York, United States