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Not Yet Recruiting 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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07686289). StuddyBuddy aggregates publicly available trial information.