Retinal Oxygen Metabolism in Children With Myopia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Myopia. Basic parameters: 8 years — 13 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Retinal oxygen extraction [Time frame: Study Day 1]
Secondary outcome measures (7)
- Choroidal and retinal blood flow [Time frame: Study Day 1]
- Choroidal and central retinal thickness [Time frame: Study Day 1]
- Retinal and choroidal vessel density [Time frame: Study Day 1]
- Lifestyle factors [Time frame: Study Day 1]
- Axial eye length [Time frame: Study Day 1]
- Intraocular pressure [Time frame: Study Day 1]
- Refraction in cycloplegia [Time frame: Study Day 1]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Austria · 1 center
- Department of Clinical Pharmacology, Medical University of Vienna, Austria — Vienna
Identifiers
NCT: NCT07473401 · OPHT-120825