Ocular Blood Flow Assessment in Glaucoma (OBAMAg)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02178085|
Recruitment Status : Recruiting
First Posted : June 30, 2014
Last Update Posted : August 10, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Glaucoma||Other: Flow imaging||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||62 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Ocular Blood-flow Assessment by Magnetic Resonance Angiography in Glaucoma|
|Actual Study Start Date :||March 2015|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||September 2019|
Experimental: Flow imaging
Glaucoma patients and healthy subjects who will undergo ocular flow imaging
Other: 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.
- Arterial blood flow [ Time Frame: Day 1 ]Measure of the mean arterial blood flow during the cardiac cycle in the ophthalmic artery.
- Vascular flow curves [ Time Frame: Day 1 ]Temporal and amplitude parameters of vascular flow curves (arteries and veins)
- Cerebrospinal fluid (CSF) dynamic [ Time Frame: Day 1 ]Temporal and amplitude parameters of cerebrospinal fluid (CSF) curves measured in the optic nerve sheath.
- Treatment response [ Time Frame: Day 180 ]
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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02178085
|Contact: Olivier Balédent, PhD||+33 3 22 66 86 email@example.com|
|Amiens, Picardie, France, 80054|
|Contact: Olivier Balédent, PhD +33 3 22 66 86 73 firstname.lastname@example.org|
|Sub-Investigator: Solange Milazzo, MD, PhD|
|Principal Investigator: Olivier Baledent, PhD|
|Sub-Investigator: Véronique Promelle, MD|
|Centre d'ophtalmologie Victor Pauchet||Not yet recruiting|
|Amiens, Picardie, France, 80090|
|Contact: Fabrice Thomas, MD +33 3 22 91 75 44|
|Principal Investigator: Fabrice Thomas, MD|
|Principal Investigator:||Olivier Balédent, PhD||CHU Amiens|