Comparing Myopia Treatments in Youth: Defocus Spectacles, Glasses, and Ortho-K (NCT06278974) | Clinical Trial Compass
RecruitingNot Applicable
Comparing Myopia Treatments in Youth: Defocus Spectacles, Glasses, and Ortho-K
China90 participantsStarted 2023-11-10
Plain-language summary
The research project titled "A Comparative Study on the Clinical Efficacy, Quality of Life, and Cost of Use of Peripheral Defocus Spectacles, Frame Glasses, and Orthokeratology Lenses in Myopic Children and Adolescents" aims to evaluate different non-surgical myopia correction methods in children. It focuses on assessing the impact of peripheral defocus spectacles, frame glasses, and orthokeratology lenses on the quality of life, clinical effectiveness, and costs associated with each method. The study is a prospective cohort study involving 90 children aged 8-17 years with myopia ranging from -1.00D to -6.00D. It aims to compare the psychological, social, and educational aspects of these correction methods, alongside their costs and clinical outcomes over a period of one year.
Who can participate
Age range
7 Years – 17 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:
* Children aged 7-17 years.
* Myopia between -1.00D and -6.00D; astigmatism \<±1.5D; best corrected visual acuity ≥1.0.
* First-time spectacle wearers who use a single correction method and meet the indications for it (any one of orthokeratology lenses, single-vision frame glasses, or myopia control frame glasses)
* Willing to participate in the entire research process and complete all the examinations, questionnaires and cost records as required.
* Be able to maintain contact throughout the research period, such as having a fixed address and contact information.
Exclusion Criteria:
* History of strabismus, amblyopia, refractive disparity or retinal diseases
* Previous history of eye surgery
* Severe psychological disorders or behavioral problems
* History of allergy to contact lenses or contact lens care solutions
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.