MyopiaNCT06085430
Kubota Glass Parameter Refinement Study
A study testing Kubota Glass in people with Myopia and Myopia, Progressive, run by Kubota Vision Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia, Myopia, Progressive, Vision Disorders
- What is being tested?
- Kubota Glass
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2023to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Various Stimulus Characteristics on Myopic Progression Using Kubota Glass
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.
Read the 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
- Being tested
- Kubota Glass
- Keywords
- myopia, spectacles
- Medical subject headings
- Myopia, Myopia, Degenerative, Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kubota GlassDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Right eyes: Treatment | Experimental | Not described Receives: Device: Kubota Glass |
| Left eyes: Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Axial length
Change in axial length as measured by optical biometry after the use of Kubota Glass
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2023
- Study start1 Nov 2023
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kubota Vision Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06085430
- Sponsor's protocol ID
- KV-JAX-RCT-001
- Status last verified
- Dec 2024
- First submitted
- 10 Oct 2023
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Upon reasonable request with a plan approved for what the data will be used for, data sharing might be considered
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Various Stimulus Characteristics on Myopic Progression Using Kubota Glass
- ClinicalTrials.gov ID
- NCT06085430
- Acronym / sponsor ID
- KV-JAX-RCT-001
- Conditions
- Myopia, Myopia, Progressive, Vision Disorders
- Keywords
- myopia, spectacles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Kubota Vision Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 17 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Right eyes: Treatment | Experimental | Device: Kubota Glass |
| Left eyes: Control | No intervention | – |
Who may qualify
- Ages
- 8 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kubota GlassKubota 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. | Device | Right eyes: Treatment |
Primary outcome
Axial length
Time frame: 2 hours
Change in axial length as measured by optical biometry after the use of Kubota Glass
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Individual participant dataSharing planned: Undecided. Upon reasonable request with a plan approved for what the data will be used for, data sharing might be considered
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kubota Glass in people with Myopia and Myopia, Progressive, run by Kubota Vision Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Axial length (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2024.