A Controlled Evaluation of Optical Defocus Parameters on Transient Changes in Axial Length Using … (NCT07686289) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Controlled Evaluation of Optical Defocus Parameters on Transient Changes in Axial Length Using Kubota Glass
35 participantsStarted 2026-07-06
Plain-language 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.
Who can participate
Age range
8 Years – 24 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.