Evaluation of Orthokeratology Lenses With a 5MM Optic Zone Diameter (NCT07751172) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Evaluation of Orthokeratology Lenses With a 5MM Optic Zone Diameter
United States, Spain70 participantsStarted 2026-08
Plain-language summary
To evaluate the clinical performance and user-reported experience of Paragon CRT contact lenses with a 5mm Optic Zone Diameter (OZD)
Who can participate
Age range
7 Years – 35 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 6- 35 years of age
. If under 18 years old they are accompanied by a parent or legal guardian who is able to read, understand and sign the parental information and permission document
. Have had a self-reported visual exam in the last two years
. Are able to read (or be read to), understand and sign the assent document if under 18 years old or are able to read, understand and sign the consent document if aged 18 or older
. Are willing to comply with the wear schedule (approximately 8 hours per night for every night, while sleeping)
. Are willing to comply with the visit schedule
. Have a refractive spherical component of their prescription between -0.50 and up to -6.00 diopters (inclusive) AND a refractive cylinder of no more than -1.75 diopters
. Have a refractive spherical component ≥ cylinder component
Exclusion criteria
. Present at screening visit with the presence of ocular or systemic disease or report the use medications which might interfere with orthokeratology contact lens wear, such as keratoconus, diabetes mellitus, steroid eye drops
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.
What they're measuring
1
Comfort at 5 Minutes and 1 Month After Final Lens Dispense
. Have a post-treatment predicted flat K value ≤38.00D (e.g. Patient baseline flat keratometry value = 40.00, patient has 2.00D of myopic refractive error. 40.00-2.00= 38.00D)
. Have a known sensitivity to the diagnostic sodium fluorescein to be used in the study
. Are pregnant, planning a pregnancy or lactating
. Have amblyopia
. Have presbyopia or has dependence on spectacles for near work over the contact lenses
. Present at screening visit with the presence of clinically significant (grade ≥3; ISO scale) anterior segment abnormalities.
. Present at screening visit with slit lamp findings that would contraindicate orthokeratology contact lens wear such as: