- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02178085
Ocular Blood Flow Assessment in Glaucoma (OBAMAg)
Ocular Blood-flow Assessment by Magnetic Resonance Angiography in Glaucoma
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.
Study Overview
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Olivier Balédent, PhD
- Phone Number: +33 3 22 66 86 73
- Email: olivier.baledent@chu-amiens.fr
Study Locations
-
-
Picardie
-
Amiens, Picardie, France, 80054
- Recruiting
- CHU Amiens
-
Contact:
- Olivier Balédent, PhD
- Phone Number: +33 3 22 66 86 73
- Email: olivier.baledent@chu-amiens.fr
-
Sub-Investigator:
- Solange Milazzo, MD, PhD
-
Principal Investigator:
- Olivier Baledent, PhD
-
Sub-Investigator:
- Véronique Promelle, MD
-
Amiens, Picardie, France, 80090
- Not yet recruiting
- Centre d'ophtalmologie Victor Pauchet
-
Contact:
- Fabrice Thomas, MD
- Phone Number: +33 3 22 91 75 44
-
Principal Investigator:
- Fabrice Thomas, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 .
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Flow imaging
Glaucoma patients and healthy subjects who will undergo ocular flow imaging
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Arterial blood flow
Time Frame: Day 1
|
Measure of the mean arterial blood flow during the cardiac cycle in the ophthalmic artery.
|
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vascular flow curves
Time Frame: Day 1
|
Temporal and amplitude parameters of vascular flow curves (arteries and veins)
|
Day 1
|
Cerebrospinal fluid (CSF) dynamic
Time Frame: Day 1
|
Temporal and amplitude parameters of cerebrospinal fluid (CSF) curves measured in the optic nerve sheath.
|
Day 1
|
Treatment response
Time Frame: Day 180
|
Determination of treatment response
The three conditions must be true to declare a patient responder to treatment. |
Day 180
|
Collaborators and Investigators
Investigators
- Principal Investigator: Olivier Balédent, PhD, CHU Amiens
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI2014_843_0007
- 2014-A00847-40 (Registry Identifier: IDRCB)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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