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.
調査の概要
詳細な説明
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.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Picardie
-
Amiens、Picardie、フランス、80054
- 募集
- CHU Amiens
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コンタクト：
- Olivier Balédent, PhD
- 電話番号：+33 3 22 66 86 73
- メール：olivier.baledent@chu-amiens.fr
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副調査官：
- Solange Milazzo, MD, PhD
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主任研究者：
- Olivier Baledent, PhD
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副調査官：
- Véronique Promelle, MD
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Amiens、Picardie、フランス、80090
- まだ募集していません
- Centre d'ophtalmologie Victor Pauchet
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コンタクト：
- Fabrice Thomas, MD
- 電話番号：+33 3 22 91 75 44
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主任研究者：
- Fabrice Thomas, MD
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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 .
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：基礎科学
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Flow imaging
Glaucoma patients and healthy subjects who will undergo ocular 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.
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Arterial blood flow
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Vascular flow curves
時間枠：Day 1
|
Temporal and amplitude parameters of vascular flow curves (arteries and veins)
|
Day 1
|
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Cerebrospinal fluid (CSF) dynamic
時間枠：Day 1
|
Temporal and amplitude parameters of cerebrospinal fluid (CSF) curves measured in the optic nerve sheath.
|
Day 1
|
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Treatment response
時間枠：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
|
協力者と研究者
捜査官
- 主任研究者：Olivier Balédent, PhD、CHU Amiens
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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