Ocular Blood Flow Assessment in Glaucoma

NCT ID: NCT02178085

Last Updated: 2018-08-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2019-09-30

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.

Conditions

Glaucoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Flow imaging

Glaucoma patients and healthy subjects who will undergo ocular flow imaging

Group Type: EXPERIMENTAL

Flow imaging

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

Flow MRI; Cine phase-constrast magnetic resonance imaging; Cerebral blood flow

Eligibility 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 .

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Olivier Balédent, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens

Locations

CHU Amiens

Amiens, Picardie, France

Site Status: RECRUITING

Centre d'ophtalmologie Victor Pauchet

Amiens, Picardie, France

Site Status: NOT_YET_RECRUITING

Countries

France

Central Contacts

Olivier Balédent, PhD

Role: CONTACT

olivier.baledent@chu-amiens.fr

+33 3 22 66 86 73

Facility Contacts

Olivier Balédent, PhD

Role: primary

olivier.baledent@chu-amiens.fr

+33 3 22 66 86 73

Fabrice Thomas, MD

Role: primary

+33 3 22 91 75 44

Other Identifiers

2014-A00847-40

Identifier Type: REGISTRY

Identifier Source: secondary_id

PI2014_843_0007

Identifier Type: -

Identifier Source: org_study_id