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Ocular Blood Flow Assessment in Glaucoma (OBAMAg)

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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

Tracking Information
First Submitted Date  ICMJE June 18, 2014
First Posted Date  ICMJE June 30, 2014
Last Update Posted Date August 10, 2018
Actual Study Start Date  ICMJE March 2015
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 26, 2014)
Arterial blood flow [ Time Frame: Day 1 ]
Measure of the mean arterial blood flow during the cardiac cycle in the ophthalmic artery.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02178085 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2014)
  • 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
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ocular Blood Flow Assessment in Glaucoma
Official Title  ICMJE Ocular Blood-flow Assessment by Magnetic Resonance Angiography in Glaucoma
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Glaucoma
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Flow imaging
Glaucoma patients and healthy subjects who will undergo ocular flow imaging
Intervention: Other: Flow imaging
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 26, 2014)
62
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2019
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 .
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Olivier Balédent, PhD +33 3 22 66 86 73 olivier.baledent@chu-amiens.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02178085
Other Study ID Numbers  ICMJE PI2014_843_0007
2014-A00847-40 ( Registry Identifier: IDRCB )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centre Hospitalier Universitaire, Amiens
Study Sponsor  ICMJE Centre Hospitalier Universitaire, Amiens
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Olivier Balédent, PhD CHU Amiens
PRS Account Centre Hospitalier Universitaire, Amiens
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP