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NCT Number: NCT07473401

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.

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Key information

Age range

8 year–13 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Clinical Pharmacology, Medical University of Vienna, Austria

Vienna, 1090, Austria

Location contact

Gerhard Garhöfer, MD

CONTACT

+43140400 29810

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Retinal oxygen extraction

    Time frame: Study Day 1

    Retinal oxygen extraction measured with LSFG and RVA

Secondary outcomes

  1. Choroidal and retinal blood flow

    Time frame: Study Day 1

    Choroidal and retinal blood flow measured with LSFG

  2. Choroidal and central retinal thickness

    Time frame: Study Day 1

    Choroidal and central retinal thickness measured with OCT

  3. Retinal and choroidal vessel density

    Time frame: Study Day 1

    Retinal and choroidal vessel density measured with OCT-A

  4. Lifestyle factors

    Time frame: Study Day 1

    Lifestyle factors with questionnaires

  5. Axial eye length

    Time frame: Study Day 1

    Axial eye length measured with IOL-Master

  6. Intraocular pressure

    Time frame: Study Day 1

    Intraocular pressure measured with rebound tonometer

  7. Refraction in cycloplegia

    Time frame: Study Day 1

    Refraction in cycloplegia measured with Autorefractometer

Study contacts

Contact information is provided by the study sponsor or research team.

Doreen Schmidl-Schordje, MD, PhD

CONTACT

[email protected]

+43140400 29810

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 16, 2026
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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