Ocular Blood Flow Assessment in Glaucoma

Glaucoma Clinical Trial

— OBAMAg  

Official title:

Ocular Blood-flow Assessment by Magnetic Resonance Angiography in Glaucoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02178085
• Other study ID #: PI2014_843_0007
• Secondary ID: 2014-A00847-40
• Status: Recruiting
• Phase: N/A
• Start date: March 2015
• Est. completion date: September 2019

Study information

• Verified date: August 2018
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Olivier Balédent, PhD
• Phone: +33 3 22 66 86 73
• Email: olivier.baledent[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: September 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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 .

Related Conditions & MeSH terms

• Glaucoma

Intervention

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.

Locations

Country	Name	City	State
France	Centre d'ophtalmologie Victor Pauchet	Amiens	Picardie
France	CHU Amiens	Amiens	Picardie

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arterial blood flow	Measure of the mean arterial blood flow during the cardiac cycle in the ophthalmic artery.	Day 1
Secondary	Vascular flow curves	Temporal and amplitude parameters of vascular flow curves (arteries and veins)	Day 1
Secondary	Cerebrospinal fluid (CSF) dynamic	Temporal and amplitude parameters of cerebrospinal fluid (CSF) curves measured in the optic nerve sheath.	Day 1
Secondary	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.	Day 180