CompletedNot Applicable

Optical Quality of the Cornea in Orthokeratology

Spain23 participantsStarted 2025-01-13

Plain-language summary

Analyzing Optical Quality After the Use of Overnight Orthokeratology (Ortho-K)

Who can participate

Age range

12 Years – 21 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: * Patients between 8 and 21 years old. Those who accept to participate in the study. The use of Ortho-K lenses for 8 to 10 hours per night, once the risks and benefits of using Ortho-K have been explained. * Refractive error of myopia between -1.00 and -5.00 diopters (D) with astigmatism of 1.50 D or less, with-the-rule. * Best-corrected visual acuity of 20/20 or better before treatment. * Ortho-K lens centered or decentered by no more than 0.5 mm radially, determined by slit-lamp examination. Exclusion Criteria: * History of hard contact lens use and contraindications for ocular and systemic Ortho-K, determined by a routine examination. * Patients who have previously undergone any refractive modulation procedure. * Patients with any corneal pathology, dry eye, glaucoma, retinal pathology, strabismus, ptosis, amblyopia, history of ocular allergy, or infection.

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

OPTICAL QUALITY

Timeframe: 1 month after using Ortho-K

Trial details

NCT IDNCT06775509

SponsorInstitut Investigacio Sanitaria Pere Virgili

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-02-08

View on ClinicalTrials.gov More Myopia (Disorder) trials

Who can participate

Age range

12 Years – 21 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.