NCT06085430

Kubota Glass Parameter Refinement Study

Effects of Various Stimulus Characteristics on Myopic Progression Using Kubota Glass

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Kubota Vision Inc. · Industry
• Sex: All
• Age: 8 Years – 24 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Myopia
• Myopia, Progressive
• Vision Disorders

Interventions

Type	Name	Description
DEVICE	Kubota Glass	Kubota Glass employs white light producing micro-LEDs covered by masks which create a patterned target. The patterned images are defocused by micro-lenslets and projected to the retinal periphery by a central mirror. Parameters of interest to evaluate in this investigation include but are not limited to dioptric amount of defocus, brightness (cd/m2), spectrum of illumination, and shape of the target mask. In each scenario, right eyes will be exposed to the stimulus, whereas left eyes serve as controls. The order of exposures to the various stimuli will be randomized to participant and investigator.

Timeline

• Start date: 2023-11-01
• Primary completion: 2024-09-30
• Completion: 2024-09-30
• First posted: 2023-10-17
• Last updated: 2024-12-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study