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Neurovascular Coupling in Subjects With Amblyopia

Neurovascular Coupling in Subjects With Amblyopia

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01746693
Enrollment
60
Registered
2012-12-11
Start date
2014-03-31
Completion date
2023-09-02
Last updated
2022-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amblyopia ex Strabismus, Amblyopia ex Anisometropia

Keywords

retinal vessel diameter, retinal oxygen saturation, high resolution functional and anatomical imaging, inner retinal function, flicker response

Brief summary

Amblyopia is a developmental condition that is characterized by reduced vision of the eye due to the presence of a sensory impediment during visual development, such as strabismus (ocular misalignment) or anisometropia (unequal refractive error), occurring early in life. Recent studies in humans and animals point towards a cortical locus for the processing deficit in amblyopia, revealing sensory deficits at the signal cell level. If changes in retinal neuronal function are also present, is unknown. Like in the brain, blood flow in the retina is coupled to neuronal activity. This phenomenon has been measured by different study groups with non invasive techniques in the brain and retina. It has been shown in previous studies that stimulating the retina with diffuse luminant flickering light increases retinal vessel diameter and blood flow. However, it is unknown whether this is also the case in the retina of amblyopic eyes. Additionally, the introduction of blood oxygen level dependent (BOLD) fMRI also makes it possible to directly access the vascular response in the brain to visual stimuli. Therefore, the aim of the present study is to investigate the effect of luminant flickering light on retinal vessel diameter and retinal blood flow in subjects with amblyopia. Also, oxygen saturation in retinal vessels will be assessed as well as pattern ERG for assessment of retinal function. Additionally, a high resolution image of the visual pathway will be taken with 7 Tesla MRI to investigate whether anatomical or functional alterations are present.

Interventions

retinal vessel diameter, retinal oxygen saturation

retinal blood flow velocity, retinal blood flow

High resolution functional and anatomical imaging of the visual pathway

OTHERPattern electroretinography

inner retinal function

OTHERFourier domain optical coherence tomography

Blood flow in retina.

Sponsors

Medical University of Vienna
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

* Men and women aged between 18 and 55 years * Non-smokers (for at least 6 months) * Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant * Normal ophthalmic findings except amblyopia on one eye resulting from anisometropia or strabismus with a visual acuity of Snellen ≤ 0.3 with best correction on the amblyopic eye and Snellen 0.9 or better in the contralateral eye (for subjects with amblyopia) * Normal ophthalmic findings with visual acuity of Snellen ≥ 1.0 in both eyes (for control subjects)

Exclusion criteria

* Symptoms of a clinically relevant illness in the 3 weeks before the first study day * Presence or history of a severe medical condition as judged by the clinical investigator * Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study (except oral contraceptives) * Blood donation during the previous three weeks * Pregnancy, planned pregnancy or lactating * Any metallic, electric, electronic or magnetic device or object not removable except dental fillings * Claustrophobia * Epilepsia, history or family history of seizures

Design outcomes

Primary

MeasureTime frame
Retinal Vessel Diameter in Response to Flickering Light (DVA)once on the study day

Secondary

MeasureTime frame
Retinal (arterial and venous) oxygen saturationonce on the study day
Retinal blood velocity in response to flickering lightonce on the study day
High resolution functional and anatomical imaging of the visual pathwayonce on the study day
Inner Retinal Functiononce on the study day

Countries

Austria

Contacts

Primary ContactGerhard Garhoefer, MD
gerhard.garhoefer@meduniwien.ac.at+43140400

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026