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.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Picardie
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Amiens, Picardie, 프랑스, 80054
- CHU Amiens
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Amiens, Picardie, 프랑스, 80090
- Centre d'ophtalmologie Victor Pauchet
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
설명
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 .
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Arterial blood flow
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Vascular flow curves
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Olivier Balédent, PhD, CHU Amiens
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정된)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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