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Retinal Oxygen Metabolism in Children With Myopia

Retinal Oxygen Metabolism in Children With Myopia

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07473401
Enrollment
80
Registered
2026-03-16
Start date
2026-05-11
Completion date
2027-01-02
Last updated
2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia

Keywords

Retinal oxygen extraction, blood flow, Vessel density

Brief 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.

Interventions

None listed

Sponsors

Medical University of Vienna
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
8 Years to 13 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Retinal oxygen extractionStudy Day 1Retinal oxygen extraction measured with LSFG and RVA

Secondary

MeasureTime frameDescription
Choroidal and retinal blood flowStudy Day 1Choroidal and retinal blood flow measured with LSFG
Choroidal and central retinal thicknessStudy Day 1Choroidal and central retinal thickness measured with OCT
Retinal and choroidal vessel densityStudy Day 1Retinal and choroidal vessel density measured with OCT-A
Lifestyle factorsStudy Day 1Lifestyle factors with questionnaires
Axial eye lengthStudy Day 1Axial eye length measured with IOL-Master
Intraocular pressureStudy Day 1Intraocular pressure measured with rebound tonometer
Refraction in cycloplegiaStudy Day 1Refraction in cycloplegia measured with Autorefractometer

Countries

Austria

Contacts

CONTACTDoreen Schmidl-Schordje, MD, PhD
doreen.schmidl@meduniwien.ac.at+43140400 29810
PRINCIPAL_INVESTIGATORDoreen Schmidl-Schordje, MD, PhD

Department of Clinical Pharmacology, Medical University of Vienna

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026