Kubota Glass Parameter Refinement Study

Completed · Not applicable

Conditions studied: Myopia, Myopia, Progressive, Vision Disorders

In brief

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.

Key facts

Study ID

NCT06085430

Run by

Kubota Vision Inc.

People needed

15

Starts

2023-11-01

Expected to finish

2024-09-30

Last updated by the study team

2024-12-12

Who can join

Age: 8 and older, up to 24. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• InOptix Eyecare Center — Jacksonville, Florida, United States

Full record on ClinicalTrials.gov

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