Effect of Diffusion Optics Technology (DOT) Spectacle Lenses on Choroidal Thickness (NCT05617794) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Effect of Diffusion Optics Technology (DOT) Spectacle Lenses on Choroidal Thickness
Canada30 participantsStarted 2023-01-18
Plain-language summary
The objective of the study is to measure the effect of Diffusion Optics Technology (DOT) spectacle lenses on the choroidal thickness and choroidal vascularity index compared to control lenses.
Who can participate
Age range
8 Years – 14 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:
* Are 8-14 years of age;
* Are able to read (or be read to), understand and sign the assent document;
* Are accompanied by a parent or legal guardian who is able to read, understand and sign the parental information and permission document;
* Are emmetropic by non-cycloplegic auto-refraction, which means both refractive meridians should be within +1.00D and -1.00D inclusively;
* Are willing and able to follow instructions.
Exclusion Criteria:
* Are participating in any concurrent interventional clinical or research study;
* Have a history of myopia control treatment in the past year;
* Have amblyopia in either eye or known to have any other binocular vision disorder, such as accommodative insufficiency;
* Have any known active ocular disease and/or infection;
* Have a systemic condition that in the opinion of the investigator may affect a study outcome variable. Examples include diabetes mellitus, hyperthyroidism;
* Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable. Examples include Atropine eye drops;
* Have undergone strabismus surgery, refractive error surgery or intraocular surgery;
* Are a child of a member of the study team.
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.