Retinal Oxygen Metabolism in Children With Myopia
ConditionMyopia
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age8-13
SponsorMedical University of Vienna
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
40 children with myopia and 40 healthy age- and sex-matched controls
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
80 Participants
are grouped into 2 trial groupsGroup A: children with myopia
Group B: healthy age- and sex-matched controls
Trial outcomes
Primary outcomes
1
Retinal oxygen extraction
Retinal oxygen extraction measured with LSFG and RVA
Time frame
Study Day 1Secondary outcomes
1
Choroidal and retinal blood flow
Choroidal and retinal blood flow measured with LSFG
Time frame
Study Day 12
Choroidal and central retinal thickness
Choroidal and central retinal thickness measured with OCT
Time frame
Study Day 13
Retinal and choroidal vessel density
Retinal and choroidal vessel density measured with OCT-A
Time frame
Study Day 14
Lifestyle factors
Lifestyle factors with questionnaires
Time frame
Study Day 1Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: