Kubota Glass Parameter Refinement Study

Kubota Vision

Status

Not yet enrolling

Conditions

Myopia

Vision Disorders

Myopia, Progressive

Treatments

Device: Kubota Glass

Study type

Interventional

Funder types

Industry

Identifiers

NCT06085430

KV-JAX-RCT-001

Details and patient eligibility

About

Length of the eye will be measured in subjects exposed to various stimulus characteristics using an electronic spectacle which presents illuminated targets to the eye. The results will be analyzed to determine which stimulus characteristics may be most beneficial for use in the device.

Full description

Axial length measurements will be taken before and after two-hour monocular exposure to various stimulus characteristics using an electronic spectacle which presents illuminated defocus targets to the retina. Areas of investigation include the dioptric amount of defocus, the intensity of illumination, the spectrum of illumination, and the shape of the illumination target. The transient axial length results will be analyzed to determine which stimulus characteristics may be most beneficial for slowing myopic eye growth.

Enrollment

30 estimated patients

Sex

All

Ages

8 to 24 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Be of legal age or, if under legal age have written consent of their parent or guardian to participate.
Sign written Informed Consent (and the California Bill of Rights, if applicable).
Ages 8-24 (inclusive) and able to understand and assent to participation
Have need of optical correction for myopia, from -1.00 to -5.00 diopters (D).
Have a refractive astigmatism of less than -1.00 D.
Best Spectacle Corrected Visual Acuity (BSCVA) of 20/25 or better.
Be willing and able to follow instructions and attend the schedule of follow-up visits.

Exclusion criteria

Not able or willing to provide informed consent and assent
Eye injury or surgery within twelve weeks immediately prior to enrollment
Currently enrolled in an ophthalmic clinical trial
Pregnant or lactating or expect to become pregnant during the trial
Evidence of systemic or ocular abnormality, infection or disease
Any systemic disease including autoimmune disease, immunocompromising diseases, connective tissue disease, clinically significant atopic diseases, insulin dependent diabetes, use of medications including corticosteroids and antimetabolites that may affect the eye
Habitually uncorrected anisometropia ≥ 2.00
Subjects who have undergone corneal refractive surgery
Use of a treatment for myopia progression within the past 6 months, including atropine, specialized spectacle lenses, orthokeratology, specialized soft contact lenses