CompletedNot Applicable

Peripheral Relative Refractive Power of Orthokeratology Lenses

China53 participantsStarted 2020-01-10

Plain-language summary

Orthokeratology (OK) has been demonstrated to be an effective intervention for slowing axial elongation in children with myopia. The proposed mechanism of action is the induction of peripheral myopic defocus, which reduces relative peripheral hyperopia on the retina. This study aims to evaluate changes in relative peripheral retinal refraction before and after OK lens wear using wide-field multispectral retinal refractive topography. The study will also investigate the relationship between these retinal refractive changes and the effectiveness of OK in controlling axial elongation.

Who can participate

Age range

8 Years – 15 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: * 8 to 15 years old * myopia of -4.00D or lower, * regular astigmatism ≤1.50D and non-regular astigmatism ≤1.00D * intraocular pressure ≤21mmHg * understand the purpose of the study and have good hygiene and regular follow-up Exclusion Criteria: * unilateral * immunocompromised subjects with systemic diseases (such as acute or chronic sinusitis, diabetes mellitus, Down syndrome, rheumatoid arthritis, psychiatric patients, etc.) * complicated with other eye diseases that affect OK lens wearing, such as dacryocystitis, blepharitis and other inflammation, glaucoma, etc. * BCVA less than 1.0 * children with corneal curvature less than 40.00D or higher than 46.00D.

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

Changes in axial length growth(ALG)

Timeframe: Change from baseline in axial length at 12 months

Trial details

NCT IDNCT07294404

SponsorTianjin Eye Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-06-15

View on ClinicalTrials.gov More Myopia trials