Status:
COMPLETED
Kubota Glass Parameter Refinement Study
Lead Sponsor:
Kubota Vision Inc.
Conditions:
Myopia
Myopia, Progressive
Eligibility:
All Genders
8-24 years
Phase:
NA
Brief 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 ...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2024
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06085430
Start Date
November 1 2023
End Date
September 30 2024
Last Update
December 12 2024
Active Locations (1)
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1
InOptix Eyecare Center
Jacksonville, Florida, United States, 32256