Retinal Oxygen Metabolism in Children With Myopia

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Myopia

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Doreen Schmidl-Schordje, MD, PhD; Phone Number: +43140400 29810; Email: doreen.schmidl@meduniwien.ac.at

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Department of Clinical Pharmacology, Medical University of Vienna, Austria
    • Contact: Gerhard Garhöfer, MD; Phone Number: +43140400 29810

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

40 children with myopia and 40 healthy age- and sex-matched controls

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
children with myopia
healthy age- and sex-matched controls

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retinal oxygen extraction	Retinal oxygen extraction measured with LSFG and RVA	Study Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Choroidal and retinal blood flow	Choroidal and retinal blood flow measured with LSFG	Study Day 1
Choroidal and central retinal thickness	Choroidal and central retinal thickness measured with OCT	Study Day 1
Retinal and choroidal vessel density	Retinal and choroidal vessel density measured with OCT-A	Study Day 1
Lifestyle factors	Lifestyle factors with questionnaires	Study Day 1
Axial eye length	Axial eye length measured with IOL-Master	Study Day 1
Intraocular pressure	Intraocular pressure measured with rebound tonometer	Study Day 1
Refraction in cycloplegia	Refraction in cycloplegia measured with Autorefractometer	Study Day 1

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Investigators: Principal Investigator: Doreen Schmidl-Schordje, MD, PhD, Department of Clinical Pharmacology, Medical University of Vienna

Study record dates

Study Major Dates

• Study Start (Estimated): May 11, 2026
• Primary Completion (Estimated): January 2, 2027
• Study Completion (Estimated): January 2, 2027

Study Registration Dates

• First Submitted: December 11, 2025
• First Submitted That Met QC Criteria: March 10, 2026
• First Posted (Actual): March 16, 2026

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 10, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: blood flow; Retinal oxygen extraction; Vessel density
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: OPHT-120825

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No