Ignite Creation Date:
2024-05-06 @ 8:53 AM
Last Modification Date:
2024-10-26 @ 12:06 PM
Study NCT ID:
NCT02849405
Status:
COMPLETED
Last Update Posted:
2024-03-28
First Post:
2016-07-14
Brief Title:
Evaluation of the Capacity of a Camera to Identify Signs of Arteriosclerosis in Retinal Arterioles
Sponsor:
Jean-Claude Tardif
Organization:
Montreal Heart Institute
Study Overview
Official Title:
Preliminary Evaluation of the Capacity of a Metabolic Hyperspectral Retinal Camera MHRC to Identify an Arteriosclerosis Spectral Signature in Retinal Arterioles
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Arteriosclerosis is a degenerative and dysmetabolic disease of the arterial walls It is known to be the principal cause of coronary artery disease CAD Arteriosclerosis has an impact on the entire vascularization including the microvascularization The retina is a nervous tissue that is supported by microvascularization Therefore systemic diseases that affect the nervous or the cardiovascular system are susceptible to have manifestations in the retina Retinal signs associated to the risks to develop CAD qualitative appreciation diameter and appearance of arterioles have been suggested A quantitative approach would strengthen the interpretation of these evaluations
The Metabolic Hyperspectral Retinal Camera MHRC - the experimental instrument - has the capacity to identify and quantify a variety of biomolecules specific to the retina and the optic nerve
The purpose of this pilot study is to determine if the MHRC has the capacity to detect a specific hyperspectral signature in the retinal arterioles of subjects suffering from arteriosclerosis
The Metabolic Hyperspectral Retinal Camera MHRC - the experimental instrument - has the capacity to identify and quantify a variety of biomolecules specific to the retina and the optic nerve
The purpose of this pilot study is to determine if the MHRC has the capacity to detect a specific hyperspectral signature in the retinal arterioles of subjects suffering from arteriosclerosis
Detailed Description:
In this pilot study the main goal is to evaluate the capacity of the Metabolic Hyperspectral Retinal Camera MHRC - the experimental instrument - to identify the presence of a specific hyperspectral signature in the retinal arterioles of subjects suffering from arteriosclerosis while this signature should not be present in the retinal arterioles of control subjects considered healthy and without arteriosclerosis risk factors The study is open non-controlled and without randomization or placebo
30 subjects of each group will be enrolled in the study for a total of 60 subjects Recruitment will take place at the Montreal Heart Institute Montreal Quebec Canada and will be led by the research team of the Principal Investigator Specific inclusionexclusion criteria will differentiate subjects in each group Once subjects fitting the inclusionexclusion criteria will be identified they will be enrolled and asked to sign the informed consent form approved by the Research Ethics and New Technology Development Committee Montreal Heart Institute
Following this step an ophthalmic examination will be performed During this examination both eyes will be evaluated in order to detect the presence of eye pathologies advanced cataracts venous occlusion age-related macular degeneration or glaucoma that could interfere with the analysis of the MHRC optical imaging results The ophthalmic examination consists first of a slit-lamp evaluation and secondly of an optic coherence tomography OCT plus a color image of the fundus standard instruments commonly used in ophthalmology clinics following the instillation of eye drops to dilate the pupils The whole examination should last 45 minutes it takes 15 to 20 minutes for the pupil to be sufficiently dilated to carry out the examinations If the ophthalmic examination does not reveal any of the exclusion criteria in the next minutes the subject will be asked to undergo the baseline MHRC examination This baseline imaging session will last a maximum of 15 minutes
All data according to the light signal spectrum will be analyzed subsequently Only depersonalized data identified solely by the subject number will be used by the investigators
Risks associated to the subjects participation in this research project have been evaluated Pupil dilation will be necessary to obtain quality images of the retina using conventional imaging techniques OCT and fundus and with the MHRC The subjects pupils will remain dilated for 4 to 6 hours afterward which may cause significant glare in areas where light is strong The MHRC is a research instrument which images the retina non-invasively and Health Canada authorization has been obtained for its use in the context of this study The only foreseeable harm connected to its use is discomfort connected to the injection of light into the eye The power of the monochromatic light source has been calculated to be well below the recommended exposure limits Very rigorous verifications were made according to the parameters fixed by the American National Standard for safe use of laser ANSI 1361 for laser radiation exposure
Finally all conflicts of interested are declared in the protocol and the informed consent form Measures are in place to mitigate them in order to maintain research and data analysis integrity
30 subjects of each group will be enrolled in the study for a total of 60 subjects Recruitment will take place at the Montreal Heart Institute Montreal Quebec Canada and will be led by the research team of the Principal Investigator Specific inclusionexclusion criteria will differentiate subjects in each group Once subjects fitting the inclusionexclusion criteria will be identified they will be enrolled and asked to sign the informed consent form approved by the Research Ethics and New Technology Development Committee Montreal Heart Institute
Following this step an ophthalmic examination will be performed During this examination both eyes will be evaluated in order to detect the presence of eye pathologies advanced cataracts venous occlusion age-related macular degeneration or glaucoma that could interfere with the analysis of the MHRC optical imaging results The ophthalmic examination consists first of a slit-lamp evaluation and secondly of an optic coherence tomography OCT plus a color image of the fundus standard instruments commonly used in ophthalmology clinics following the instillation of eye drops to dilate the pupils The whole examination should last 45 minutes it takes 15 to 20 minutes for the pupil to be sufficiently dilated to carry out the examinations If the ophthalmic examination does not reveal any of the exclusion criteria in the next minutes the subject will be asked to undergo the baseline MHRC examination This baseline imaging session will last a maximum of 15 minutes
All data according to the light signal spectrum will be analyzed subsequently Only depersonalized data identified solely by the subject number will be used by the investigators
Risks associated to the subjects participation in this research project have been evaluated Pupil dilation will be necessary to obtain quality images of the retina using conventional imaging techniques OCT and fundus and with the MHRC The subjects pupils will remain dilated for 4 to 6 hours afterward which may cause significant glare in areas where light is strong The MHRC is a research instrument which images the retina non-invasively and Health Canada authorization has been obtained for its use in the context of this study The only foreseeable harm connected to its use is discomfort connected to the injection of light into the eye The power of the monochromatic light source has been calculated to be well below the recommended exposure limits Very rigorous verifications were made according to the parameters fixed by the American National Standard for safe use of laser ANSI 1361 for laser radiation exposure
Finally all conflicts of interested are declared in the protocol and the informed consent form Measures are in place to mitigate them in order to maintain research and data analysis integrity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None