Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

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.


Condition or disease Intervention/treatment Phase
Glaucoma Other: Flow imaging Not Applicable

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.


Layout table for study information
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Other Names:
  • Flow MRI
  • Cine phase-constrast magnetic resonance imaging
  • Cerebral blood flow




Primary Outcome Measures :
  1. Arterial blood flow [ Time Frame: Day 1 ]
    Measure of the mean arterial blood flow during the cardiac cycle in the ophthalmic artery.


Secondary Outcome Measures :
  1. Vascular flow curves [ Time Frame: Day 1 ]
    Temporal and amplitude parameters of vascular flow curves (arteries and veins)

  2. Cerebrospinal fluid (CSF) dynamic [ Time Frame: Day 1 ]
    Temporal and amplitude parameters of cerebrospinal fluid (CSF) curves measured in the optic nerve sheath.

  3. Treatment response [ Time Frame: Day 180 ]

    Determination of treatment response

    1. Measurement of ocular tone (21 mmHg threshold under which the patient may be responder to treatment value)
    2. Extent of the visual field (if stable patient responder)
    3. Measure optic disc (if stable patient responder)

    The three conditions must be true to declare a patient responder to treatment.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 .

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02178085


Contacts
Layout table for location contacts
Contact: Olivier Balédent, PhD +33 3 22 66 86 73 olivier.baledent@chu-amiens.fr

Locations
Layout table for location information
France
CHU Amiens Recruiting
Amiens, Picardie, France, 80054
Contact: Olivier Balédent, PhD    +33 3 22 66 86 73    olivier.baledent@chu-amiens.fr   
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         
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
Layout table for investigator information
Principal Investigator: Olivier Balédent, PhD CHU Amiens

Layout table for additonal information
Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT02178085     History of Changes
Other Study ID Numbers: PI2014_843_0007
2014-A00847-40 ( Registry Identifier: IDRCB )
First Posted: June 30, 2014    Key Record Dates
Last Update Posted: August 10, 2018
Last Verified: August 2018

Keywords provided by Centre Hospitalier Universitaire, Amiens:
glaucoma
phase-contrast MRI
blood flow
cerebrospinal fluid

Additional relevant MeSH terms:
Layout table for MeSH terms
Glaucoma
Ocular Hypertension
Eye Diseases