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Neurovascular Coupling in Subjects With Amblyopia

Primary Purpose

Amblyopia ex Strabismus, Amblyopia ex Anisometropia

Status
Recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Dynamic Vessel Analyzer
Laser Doppler Velocimetry
7-Tesla MRI
Pattern electroretinography
Fourier domain optical coherence tomography
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Amblyopia ex Strabismus focused on measuring retinal vessel diameter, retinal oxygen saturation, high resolution functional and anatomical imaging, inner retinal function, flicker response

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Clinical Pharmacology, Medical University of ViennaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

amblyopia ex anisometropia

amblyopia ex strabismus

control subjects

Arm Description

20 male and female volunteers with amblyopia ex anisometropia

20 male and female volunteers with amblyopia ex strabismus

20 healthy male and female control subjects

Outcomes

Primary Outcome Measures

Retinal Vessel Diameter in Response to Flickering Light (DVA)

Secondary Outcome Measures

Retinal (arterial and venous) oxygen saturation
Retinal blood velocity in response to flickering light
High resolution functional and anatomical imaging of the visual pathway
Inner Retinal Function

Full Information

First Posted
December 7, 2012
Last Updated
April 6, 2022
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT01746693
Brief Title
Neurovascular Coupling in Subjects With Amblyopia
Official Title
Neurovascular Coupling in Subjects With Amblyopia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 2014 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amblyopia ex Strabismus, Amblyopia ex Anisometropia
Keywords
retinal vessel diameter, retinal oxygen saturation, high resolution functional and anatomical imaging, inner retinal function, flicker response

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
amblyopia ex anisometropia
Arm Type
Experimental
Arm Description
20 male and female volunteers with amblyopia ex anisometropia
Arm Title
amblyopia ex strabismus
Arm Type
Experimental
Arm Description
20 male and female volunteers with amblyopia ex strabismus
Arm Title
control subjects
Arm Type
Experimental
Arm Description
20 healthy male and female control subjects
Intervention Type
Device
Intervention Name(s)
Dynamic Vessel Analyzer
Intervention Description
retinal vessel diameter, retinal oxygen saturation
Intervention Type
Other
Intervention Name(s)
Laser Doppler Velocimetry
Intervention Description
retinal blood flow velocity, retinal blood flow
Intervention Type
Device
Intervention Name(s)
7-Tesla MRI
Intervention Description
High resolution functional and anatomical imaging of the visual pathway
Intervention Type
Other
Intervention Name(s)
Pattern electroretinography
Intervention Description
inner retinal function
Intervention Type
Other
Intervention Name(s)
Fourier domain optical coherence tomography
Intervention Description
Blood flow in retina.
Primary Outcome Measure Information:
Title
Retinal Vessel Diameter in Response to Flickering Light (DVA)
Time Frame
once on the study day
Secondary Outcome Measure Information:
Title
Retinal (arterial and venous) oxygen saturation
Time Frame
once on the study day
Title
Retinal blood velocity in response to flickering light
Time Frame
once on the study day
Title
High resolution functional and anatomical imaging of the visual pathway
Time Frame
once on the study day
Title
Inner Retinal Function
Time Frame
once on the study day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gerhard Garhoefer, MD
Phone
+43140400
Ext
2981
Email
gerhard.garhoefer@meduniwien.ac.at
Facility Information:
Facility Name
Department of Clinical Pharmacology, Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gerhard Garhoefer, MD
Phone
+43140400
Ext
2981
Email
gerhard.garhoefer@meduniwien.ac.at
First Name & Middle Initial & Last Name & Degree
Gerhard Garhoefer, MD

12. IPD Sharing Statement

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Neurovascular Coupling in Subjects With Amblyopia

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