Neurovascular Coupling in Subjects With Amblyopia

Sponsor
Medical University of Vienna (Other)
Overall Status
Recruiting
CT.gov ID
NCT01746693
Collaborator
(none)
60
1
3
114.1
0.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Dynamic Vessel Analyzer
  • Other: Laser Doppler Velocimetry
  • Device: 7-Tesla MRI
  • Other: Pattern electroretinography
  • Other: Fourier domain optical coherence tomography
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Neurovascular Coupling in Subjects With Amblyopia
Actual Study Start Date :
Mar 1, 2014
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Sep 2, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: amblyopia ex anisometropia

20 male and female volunteers with amblyopia ex anisometropia

Device: Dynamic Vessel Analyzer
retinal vessel diameter, retinal oxygen saturation

Other: Laser Doppler Velocimetry
retinal blood flow velocity, retinal blood flow

Device: 7-Tesla MRI
High resolution functional and anatomical imaging of the visual pathway

Other: Pattern electroretinography
inner retinal function

Other: Fourier domain optical coherence tomography
Blood flow in retina.

Experimental: amblyopia ex strabismus

20 male and female volunteers with amblyopia ex strabismus

Device: Dynamic Vessel Analyzer
retinal vessel diameter, retinal oxygen saturation

Other: Laser Doppler Velocimetry
retinal blood flow velocity, retinal blood flow

Device: 7-Tesla MRI
High resolution functional and anatomical imaging of the visual pathway

Other: Pattern electroretinography
inner retinal function

Other: Fourier domain optical coherence tomography
Blood flow in retina.

Experimental: control subjects

20 healthy male and female control subjects

Device: Dynamic Vessel Analyzer
retinal vessel diameter, retinal oxygen saturation

Other: Laser Doppler Velocimetry
retinal blood flow velocity, retinal blood flow

Device: 7-Tesla MRI
High resolution functional and anatomical imaging of the visual pathway

Other: Pattern electroretinography
inner retinal function

Other: Fourier domain optical coherence tomography
Blood flow in retina.

Outcome Measures

Primary Outcome Measures

  1. Retinal Vessel Diameter in Response to Flickering Light (DVA) [once on the study day]

Secondary Outcome Measures

  1. Retinal (arterial and venous) oxygen saturation [once on the study day]

  2. Retinal blood velocity in response to flickering light [once on the study day]

  3. High resolution functional and anatomical imaging of the visual pathway [once on the study day]

  4. Inner Retinal Function [once on the study day]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Clinical Pharmacology, Medical University of Vienna Vienna Austria 1090

Sponsors and Collaborators

  • Medical University of Vienna

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gerhard Garhofer, Assoc. Prof. PD Dr., Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01746693
Other Study ID Numbers:
  • OPHT-291012
First Posted:
Dec 11, 2012
Last Update Posted:
Apr 7, 2022
Last Verified:
Apr 1, 2022
Keywords provided by Gerhard Garhofer, Assoc. Prof. PD Dr., Medical University of Vienna
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 7, 2022