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NCT07686289
A Controlled Evaluation of Optical Defocus Parameters on Transient Changes in Axial Length Using Kubota Glass
Conditions: Myopia
Sex: All
Ages: 8 Years – 24 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 35
Sponsor: Kubota Vision Inc.
Summary
This study will assess the optimal performance characteristics of optical defocus on transient changes in axial length with Kubota Glass, using a randomized, double-masked, 5-treatment, 5-period crossover design with contralateral eye control.
Eligibility Criteria
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).
* Be between age 8-24 (inclusive) and able to understand and assent to participation.
* Have a spherical component of spectacle prescription between -1.00 and -5.00 diopters (D) (inclusive) in each eye.
* Have a refractive astigmatism of less than or equal to -1.00 D in each eye.
* Have axial length between 23.00 and 25.99 millimeters (mm) in each eye.
* Best Spectacle Corrected Visual Acuity (BSCVA) of 20/25 or better in each eye.
* Be willing and able to follow instructions and attend the schedule of follow-up visits.
Exclusion Criteria:
* Unable or unwilling 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 (by self-report).
* Evidence of systemic or ocular abnormality, infection or disease.
* Use of medications that may affect the eye (including, but not limited to, corticosteroids and antimetabolites).
* Anisometropia ≥ 2.00.
* Subjects who have undergone corneal refractive surgery.
* Use atropine or other anticholinergic drug within the past month.
* Employees or immediate family members of employees of study sites or sponsor.
Source: ClinicalTrials.gov (NCT07686289). StuddyBuddy aggregates publicly available trial information.