Slowing Axial Elongation in Pediatric Myopia Using C.A.R.E. Technology (NCT07465900) | Clinical Trial Compass
CompletedNot Applicable
Slowing Axial Elongation in Pediatric Myopia Using C.A.R.E. Technology
Egypt100 participantsStarted 2024-01-15
Plain-language summary
This prospective interventional study evaluates the effectiveness of Cylindrical Annular Refractive Element (C.A.R.E.) spectacle lenses in slowing axial elongation and myopia progression in children aged 6-12 years. A total of 100 participants with myopia ranging from -0.75 to -6.00 diopters were enrolled and prescribed C.A.R.E. spectacle lenses for full-time wear over a 12-month period. Clinical examinations are conducted at baseline, 6 months, and 12 months and include measurements of axial length, cycloplegic refraction, and visual acuity.
The primary outcome measure is the change in axial length over the 12-month study period. Secondary outcomes include changes in spherical equivalent refractive error, visual acuity, and safety outcomes related to spectacle lens wear.
Who can participate
Age range
6 Years – 12 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 6-12 years at enrollment.
* Spherical equivalent refractive error between -0.75 and -6.00 diopters.
* Astigmatism ≤1.50 diopters.
* Best-corrected visual acuity of 0.1 logMAR or better.
* Ability to comply with full-time spectacle wear.
* Informed consent obtained from parent or legal guardian.
Exclusion Criteria:
* Amblyopia or strabismus.
* Keratoconus or other corneal pathology.
* Previous myopia control treatment (e.g., atropine therapy, orthokeratology).
* History of ocular surgery.
* Systemic disease affecting vision.
* Poor compliance with spectacle wear.
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.