Retinal Oxygen Metabolism in Children With Myopia

NCT07473401 | Not Yet Recruiting

• 1 other identifier: OPHT-120825
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopia

Keywords

Retinal oxygen extraction; blood flow; Vessel density

Outcome Measures

Primary Outcomes (1)

• Retinal oxygen extraction

  Retinal oxygen extraction measured with LSFG and RVA

  Study Day 1

Secondary Outcomes (7)

• Choroidal and retinal blood flow

  Study Day 1

• Choroidal and central retinal thickness

  Study Day 1

• Retinal and choroidal vessel density

  Study Day 1

• Lifestyle factors

  Study Day 1

• Axial eye length

  Study Day 1

Study Arms (2)

children with myopia

children with myopia

healthy age- and sex-matched controls

healthy age- and sex-matched controls

Eligibility Criteria

• Age: 8 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Department of Clinical Pharmacology, Medical University of Vienna, Austria

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Doreen Schmidl-Schordje, MD, PhD

  Department of Clinical Pharmacology, Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Doreen Schmidl-Schordje, MD, PhD

CONTACT

+43140400 29810; doreen.schmidl@meduniwien.ac.at

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Priv. Doz. Dr., PhD

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: March 16, 2026
• Study Start: May 11, 2026
• Primary Completion (Estimated): January 2, 2027
• Study Completion (Estimated): January 2, 2027
• Last Updated: March 16, 2026

Record last verified: 2026-03

Locations

AU (1)