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Binocular Peripheral Myopic Defocus Using a Clinical Prototype Device

NCT05425108 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2022-07-06

No results posted yet for this study

Summary

Kubota Vision Inc. has developed a spectacle-like prototype device which is designed to be used as a light-based therapy to reduce myopia progression. In this study, we aim to observe the ocular biometric and refractive changes following binocular part-time wear of the clinical prototype device over a course of 12 months and compare that to 12 months of no clinical prototype device use (control).

Conditions

  • Myopia

Interventions

DEVICE

Binocular CP1

Binocular active projection of defocused image in the peripheral visual field

Sponsors & Collaborators

  • Kubota Vision Inc.

    lead INDUSTRY

Principal Investigators

  • Arkady Selenow, OD · Manhattan Vision Associates/Institute of Vision Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-23
Primary Completion
2023-08-31
Completion
2023-08-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05425108 on ClinicalTrials.gov