Retinal Oxygen Metabolism in Children With Myopia (NCT07473401) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Retinal Oxygen Metabolism in Children With Myopia
Austria80 participantsStarted 2026-05-11
Plain-language summary
The aim of the present study is to gain more information about retinal functional parameters in myopic children in Europe. For this purpose, a prospective case-control study in children aged between 8 and 13 years, as this is the usual age of myopia onset, will be conducted. Forty myopic children will be age- and sex-matched to non-myopic controls. Retinal oxygen extraction will be used as the main outcome parameter, as data from animal and human studies point towards an involvement of hypoxia in the disease process. In addition, other parameters probably linked to myopia will be investigated, such as retinal and choroidal blood flow as well as choroidal and retinal vessel density and anatomical structures such as choroidal and central retinal thickness. Also, questionnaires about lifestyle factors will be completed.
Who can participate
Age range
8 Years – 13 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 for children with myopia:
* Children aged between 8 and 13 years (inclusive)
* Signed informed consent of child and legal guardian
* Normal ophthalmic findings except myopia
* Cycloplegic spherical equivalent (SE) refraction ≤ -1.0dpt in both eyes
* Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant
Inclusion criteria for healthy age- and sex-matched controls:
* Children aged between 8 and 13 years (inclusive)
* Signed informed consent of child and legal guardian
* Normal ophthalmic findings
* Cycloplegic spherical equivalent (SE) refraction between +0.5dpt and -0.5dpt
* Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant
Exclusion Criteria:
* Intake of stimulating beverages containing xanthine derivatives (tea, coffee, cola-like drinks) 12 hours before the study day
* Previous eye abnormalities such as cataract, keratopathy, strabismus, amblyopia, ocular inflammation, trauma, or surgery
* History of any disease or syndrome associated with severe myopia such as Marfan syndrome, Stickler syndrome, or retinopathy of prematurity
* Non-axial cause of myopia
* BCVA less than 20/25
* Intraocular pressure ≥ 21mmHg
* Astigmatism ≤ -1.0dpt
* Anisometropia ≥ 2dpt
* Not able to read letters for visual acuity testing
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.