Neurovascular Coupling in Subjects With Amblyopia
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ClinicalTrials.gov Identifier: NCT01746693 |
Recruitment Status
:
Recruiting
First Posted
: December 11, 2012
Last Update Posted
: January 9, 2018
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Tracking Information | |||||
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First Submitted Date ICMJE | December 7, 2012 | ||||
First Posted Date ICMJE | December 11, 2012 | ||||
Last Update Posted Date | January 9, 2018 | ||||
Actual Study Start Date ICMJE | March 2014 | ||||
Estimated Primary Completion Date | January 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Retinal Vessel Diameter in Response to Flickering Light (DVA) [ Time Frame: once on the study day ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT01746693 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | Not Provided | ||||
Original Other Outcome Measures ICMJE | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Neurovascular Coupling in Subjects With Amblyopia | ||||
Official Title ICMJE | Neurovascular Coupling in Subjects With Amblyopia | ||||
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. |
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Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase | Not Applicable | ||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Basic Science |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
60 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date | April 2019 | ||||
Estimated Primary Completion Date | January 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 55 Years (Adult) | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Austria | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT01746693 | ||||
Other Study ID Numbers ICMJE | OPHT-291012 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement | Not Provided | ||||
Responsible Party | Gerhard Garhofer, Medical University of Vienna | ||||
Study Sponsor ICMJE | Medical University of Vienna | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Medical University of Vienna | ||||
Verification Date | January 2018 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |