Ocular Blood Flow Assessment in Glaucoma (OBAMAg)
Ocular Blood-flow Assessment by Magnetic Resonance Angiography in Glaucoma
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.
Studie Overzicht
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Picardie
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Amiens, Picardie, Frankrijk, 80054
- Chu Amiens
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Amiens, Picardie, Frankrijk, 80090
- Centre d'ophtalmologie Victor Pauchet
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Beschrijving
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 .
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Fundamentele wetenschap
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Flow imaging
Glaucoma patients and healthy subjects who will undergo ocular flow imaging
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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.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Arterial blood flow
Tijdsspanne: Day 1
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Measure of the mean arterial blood flow during the cardiac cycle in the ophthalmic artery.
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Day 1
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Vascular flow curves
Tijdsspanne: Day 1
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Temporal and amplitude parameters of vascular flow curves (arteries and veins)
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Day 1
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Cerebrospinal fluid (CSF) dynamic
Tijdsspanne: Day 1
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Temporal and amplitude parameters of cerebrospinal fluid (CSF) curves measured in the optic nerve sheath.
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Day 1
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Treatment response
Tijdsspanne: Day 180
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Determination of treatment response
The three conditions must be true to declare a patient responder to treatment. |
Day 180
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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Olivier Balédent, PhD, Chu Amiens
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Geschat)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- PI2014_843_0007
- 2014-A00847-40 (Register-ID: IDRCB)
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