MyopiaNCT07473401
Retinal Oxygen Metabolism in Children With Myopia
An observational study of Myopia, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- How many people
- 80 participants
- Where
- 1 siteAustria
- Study dates
- 11 May 2026to 2 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: 40 children with myopia and 40 healthy age- and sex-matched controls
Who may be able to join
- 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:
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- 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
Who cannot join
- 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
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- Astigmatism ≤ -1.0dpt
- Anisometropia ≥ 2dpt
- Not able to read letters for visual acuity testing
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site
Department of Clinical Pharmacology, Medical University of Vienna, Austria
Vienna, 1090
Gerhard Garhöfer, MD, +43140400 29810
About this study
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
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| children with myopia | children with myopia | |
| healthy age- and sex-matched controls | healthy age- and sex-matched controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal oxygen extraction
Retinal oxygen extraction measured with LSFG and RVA
Measured: Study Day 1
Secondary outcomes (7)
Choroidal and retinal blood flow
Choroidal and retinal blood flow measured with LSFG
Measured: Study Day 1
Choroidal and central retinal thickness
Choroidal and central retinal thickness measured with OCT
Measured: Study Day 1
Retinal and choroidal vessel density
Retinal and choroidal vessel density measured with OCT-A
Measured: Study Day 1
Lifestyle factors
Lifestyle factors with questionnaires
Measured: Study Day 1
Axial eye length
Axial eye length measured with IOL-Master
Measured: Study Day 1
Intraocular pressure
Intraocular pressure measured with rebound tonometer
Measured: Study Day 1
Refraction in cycloplegia
Refraction in cycloplegia measured with Autorefractometer
Measured: Study Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start11 May 2026 (estimated)
- Primary completion2 Jan 2027 (estimated)
- Study completion2 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doreen Schmidl, Medical University of Vienna
- Investigators
- Doreen Schmidl-Schordje, MD, PhD, Principal investigator, Department of Clinical Pharmacology, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07473401
- Sponsor's protocol ID
- OPHT-120825
- Status last verified
- Mar 2026
- First submitted
- 11 Dec 2025
- Last updated
- 16 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retinal Oxygen Metabolism in Children With Myopia
- ClinicalTrials.gov ID
- NCT07473401
- Acronym / sponsor ID
- OPHT-120825
- Conditions
- Myopia
- Keywords
- Retinal oxygen extraction, blood flow, Vessel density
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 11 May 2026 (estimated)
- Primary completion
- 2 Jan 2027 (estimated)
- Study completion
- 2 Jan 2027 (estimated)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| children with myopia | – | –children with myopia |
| healthy age- and sex-matched controls | – | –healthy age- and sex-matched controls |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 40 children with myopia and 40 healthy age- and sex-matched controls
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Retinal oxygen extraction
Time frame: Study Day 1
Retinal oxygen extraction measured with LSFG and RVA
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Doreen Schmidl-Schordje, MD, PhD principal investigator
Department of Clinical Pharmacology, Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myopia, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Doreen Schmidl-Schordje, MD, PhD (+43140400 29810, doreen.schmidl@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retinal oxygen extraction (time frame: Study Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.