Ocular Blood Flow Assessment in Glaucoma (OBAMAg)
Primary Purpose
Glaucoma
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Flow imaging
Sponsored by
About this trial
This is an interventional basic science trial for Glaucoma focused on measuring glaucoma, phase-contrast MRI, blood flow, cerebrospinal fluid
Eligibility Criteria
Inclusion Criteria:
- Adult participants
- Diagnosis of primary open angle glaucoma or normal-tension glaucoma
- Never received any anti glaucoma therapy
- Patients included in the group " normal pressure glaucoma " are patients where the diagnosis of optic neuropathy have been worn by the ophthalmologist with measured intraocular pressure <21 mmHg.
- Healthy controls will be examined by an ophthalmologist before inclusion
Exclusion Criteria:
- Anyone with a classic contraindication to MRI
- Cardiovascular comorbidities or neurovascular : uncontrolled systemic hypertension , Diabetes, heart failure , carotid stenosis , ischemic stroke or transient ischemic attack.
- Already treated glaucoma
- Prescription by the ophthalmologist another treatment than prostaglandin analogue treatment.
- Other clinical forms of glaucoma : angle closure glaucoma, neovascular glaucoma, exfoliative glaucoma, secondary glaucomas, pigment dispersion glaucoma, traumatic glaucoma, congenital glaucoma
- Presence of other ocular pathology (simple refractive error allowing 10/10 of best corrected visual acuity and mild and moderate cataracts will not be considered as a criterion for non- inclusion).
- History of intraocular or orbital surgery of less than 6 months .
Sites / Locations
- CHU AmiensRecruiting
- Centre d'ophtalmologie Victor Pauchet
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Flow imaging
Arm Description
Glaucoma patients and healthy subjects who will undergo ocular flow imaging
Outcomes
Primary Outcome Measures
Arterial blood flow
Measure of the mean arterial blood flow during the cardiac cycle in the ophthalmic artery.
Secondary Outcome Measures
Vascular flow curves
Temporal and amplitude parameters of vascular flow curves (arteries and veins)
Cerebrospinal fluid (CSF) dynamic
Temporal and amplitude parameters of cerebrospinal fluid (CSF) curves measured in the optic nerve sheath.
Treatment response
Determination of treatment response
Measurement of ocular tone (21 mmHg threshold under which the patient may be responder to treatment value)
Extent of the visual field (if stable patient responder)
Measure optic disc (if stable patient responder)
The three conditions must be true to declare a patient responder to treatment.
Full Information
NCT ID
NCT02178085
First Posted
June 18, 2014
Last Updated
August 9, 2018
Sponsor
Centre Hospitalier Universitaire, Amiens
1. Study Identification
Unique Protocol Identification Number
NCT02178085
Brief Title
Ocular Blood Flow Assessment in Glaucoma
Acronym
OBAMAg
Official Title
Ocular Blood-flow Assessment by Magnetic Resonance Angiography in Glaucoma
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (Actual)
Primary Completion Date
September 2019 (Anticipated)
Study Completion Date
September 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Background : Glaucoma is a common disease, potentially blinding, characterized by progressive damage to the optic nerve. If the intraocular pressure is the most known risk factor, however, there are cases of glaucoma scalable despite well-controlled intraocular pressure, ocular hypertension without glaucoma or glaucoma without ocular hypertension (normal tension glaucoma).
Purpose :Involvement of vascular factors in the development of glaucoma and scalability has been proved, associated with a possible loss of vascular autoregulation. The objective of this study is to quantify MRI flow of blood flows referred ophthalmic patients with glaucoma untreated comparison with control subjects.
Detailed Description
Eye vascularization, supplied by ophthalmic artery and superior ophthalmic vein is not easily accessible to routine explorations to date. Similarly the potential oscillations of the cerebrospinal fluid (CSF) around the optic nerve have not been described. Developments in magnetic resonance imaging (MRI) provide new insights into the quantitative study of blood and CSF flows through phase contrast MRI also called "flow MRI". Our hypothesis is that the ability of MRI to measure intracranial flow is applicable to the vasculature of the eye.
The MRI protocol will be applied to control adult subjects previously examined by an ophthalmologist. Structures to be imaged will be identified on a morphological sequence. Each MRI phase contrast slice (flow MRI) will be positioned perpendicularly to the flow direction. The flow MRI data will be analysed by a dedicated image processing tool which performs the vessels segmentation. For each curve of the vessel flow evolution during the cardiac cycle is reconstructed.
Glaucomatous patients will undergo a six-month follow-up to determine if they respond to their therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
glaucoma, phase-contrast MRI, blood flow, cerebrospinal fluid
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
62 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Flow imaging
Arm Type
Experimental
Arm Description
Glaucoma patients and healthy subjects who will undergo ocular flow imaging
Intervention Type
Other
Intervention Name(s)
Flow imaging
Other Intervention Name(s)
Flow MRI, Cine phase-constrast magnetic resonance imaging, Cerebral blood flow
Intervention Description
Participants will undergo morphological and then flow MRI. Flow MR images will be processed adequately to obtain quantitative values of arterial and venous flow as well as CSF flow.
Primary Outcome Measure Information:
Title
Arterial blood flow
Description
Measure of the mean arterial blood flow during the cardiac cycle in the ophthalmic artery.
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Vascular flow curves
Description
Temporal and amplitude parameters of vascular flow curves (arteries and veins)
Time Frame
Day 1
Title
Cerebrospinal fluid (CSF) dynamic
Description
Temporal and amplitude parameters of cerebrospinal fluid (CSF) curves measured in the optic nerve sheath.
Time Frame
Day 1
Title
Treatment response
Description
Determination of treatment response
Measurement of ocular tone (21 mmHg threshold under which the patient may be responder to treatment value)
Extent of the visual field (if stable patient responder)
Measure optic disc (if stable patient responder)
The three conditions must be true to declare a patient responder to treatment.
Time Frame
Day 180
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Adult participants
Diagnosis of primary open angle glaucoma or normal-tension glaucoma
Never received any anti glaucoma therapy
Patients included in the group " normal pressure glaucoma " are patients where the diagnosis of optic neuropathy have been worn by the ophthalmologist with measured intraocular pressure <21 mmHg.
Healthy controls will be examined by an ophthalmologist before inclusion
Exclusion Criteria:
Anyone with a classic contraindication to MRI
Cardiovascular comorbidities or neurovascular : uncontrolled systemic hypertension , Diabetes, heart failure , carotid stenosis , ischemic stroke or transient ischemic attack.
Already treated glaucoma
Prescription by the ophthalmologist another treatment than prostaglandin analogue treatment.
Other clinical forms of glaucoma : angle closure glaucoma, neovascular glaucoma, exfoliative glaucoma, secondary glaucomas, pigment dispersion glaucoma, traumatic glaucoma, congenital glaucoma
Presence of other ocular pathology (simple refractive error allowing 10/10 of best corrected visual acuity and mild and moderate cataracts will not be considered as a criterion for non- inclusion).
History of intraocular or orbital surgery of less than 6 months .
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Olivier Balédent, PhD
Phone
+33 3 22 66 86 73
Email
olivier.baledent@chu-amiens.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier Balédent, PhD
Organizational Affiliation
CHU Amiens
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Amiens
City
Amiens
State/Province
Picardie
ZIP/Postal Code
80054
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier Balédent, PhD
Phone
+33 3 22 66 86 73
Email
olivier.baledent@chu-amiens.fr
First Name & Middle Initial & Last Name & Degree
Solange Milazzo, MD, PhD
First Name & Middle Initial & Last Name & Degree
Olivier Baledent, PhD
First Name & Middle Initial & Last Name & Degree
Véronique Promelle, MD
Facility Name
Centre d'ophtalmologie Victor Pauchet
City
Amiens
State/Province
Picardie
ZIP/Postal Code
80090
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabrice Thomas, MD
Phone
+33 3 22 91 75 44
First Name & Middle Initial & Last Name & Degree
Fabrice Thomas, MD
12. IPD Sharing Statement
Learn more about this trial
Ocular Blood Flow Assessment in Glaucoma
We'll reach out to this number within 24 hrs