Choroidal Thickness During Changes in Intraocular Pressure and Arterial Blood Pressure
Age-related macular degeneration (AMD) and glaucoma are among the leading causes of blindness in the western world. Elevated intraocular pressure (IOP) is a well known major risk factor for glaucoma. In addition, there is growing evidence that vascular factors, including arterial hypertension and hypotension, may play a role in the pathogenesis of AMD and glaucoma. To gain more insight into these mechanisms in humans is the primary goal of the present study.
Optical coherence tomography (OCT) delivers three dimensional, volumetric reflectivity information through transparent media in vivo. Moreover, the images show a high choroidal penetration and a resolution comparable to an histologic examination when infrared light sources are used. Because of its non-invasive character, OCT provides an ideal method for diagnosis and monitoring of retinal and choroidal abnormalities.
The present study aims to investigate whether choroidal thickness is temporarily altered by changes in IOP or systemic hemodynamic parameters. IOP will be increased by the use of a suction cup technique, mean arterial blood pressure will be altered by intravenously administered Phenylephrine or Sodium-Nitroprusside.
연구 개요
상태
정황
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Vienna, 오스트리아, 1090
- Department of Clinical Pharmacology, Medical University of Vienna
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Men and women aged between 18 and 35 years, nonsmokers
- Men and women will be included in equal parts
- Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
- Normal findings in the laboratory testings unless the investigator considers an abnormality to be clinically irrelevant
- Normal ophthalmic findings, ametropia less than 1 diopter
Exclusion Criteria:
- Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
- Treatment in the previous 3 weeks with any drug (except oral contraceptives)
- Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- Blood donation during the previous 3 weeks History of hypersensitivity to the trial drugs or to drugs with a similar chemical structure
- History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with distribution, metabolism or excretion of study drugs
- History of migraine
- Pregnancy
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: Sodium-Nitroprusside
Nipruss®, Sanol-Schwarz, Monheim, Germany 0, 0.5, 1 and 2 µg/kg/min, each infusion step for 5 minutes, total infusion period of 20 minutes
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Neosynephrine®, Winthrop Breon Laboratories New York, NY, USA 0, 0.5, 1 and 2 μg/kg/min, each infusion step for 5 minutes, total infusion period of 20 minutes
Nipruss®, Sanol-Schwarz, Monheim, Germany 0, 0.5, 1 and 2 µg/kg/min, each infusion step for 5 minutes, total infusion period of 20 minutes
experimental stepwise increase of intraocular pressure while measurement of choroidal thickness suction force of 25, 50, 75, and 100 mmH
안압 측정
Optical coherence tomography is a widely used non-invasive method to image the retina and choroid.
Using a 1060nm light source coupled to a commercially available OCT system (Heidelberg Engineering, Heidelberg, Germany) allows for the measurement of choroidal thickness
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활성 비교기: Phenylephrine
Neosynephrine®, Winthrop Breon Laboratories New York, NY, USA 0, 0.5, 1 and 2 μg/kg/min, each infusion step for 5 minutes, total infusion period of 20 minutes
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Neosynephrine®, Winthrop Breon Laboratories New York, NY, USA 0, 0.5, 1 and 2 μg/kg/min, each infusion step for 5 minutes, total infusion period of 20 minutes
Nipruss®, Sanol-Schwarz, Monheim, Germany 0, 0.5, 1 and 2 µg/kg/min, each infusion step for 5 minutes, total infusion period of 20 minutes
experimental stepwise increase of intraocular pressure while measurement of choroidal thickness suction force of 25, 50, 75, and 100 mmH
안압 측정
Optical coherence tomography is a widely used non-invasive method to image the retina and choroid.
Using a 1060nm light source coupled to a commercially available OCT system (Heidelberg Engineering, Heidelberg, Germany) allows for the measurement of choroidal thickness
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활성 비교기: Suction Cup
suction force of 25, 50, 75, and 100 mmHg
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Neosynephrine®, Winthrop Breon Laboratories New York, NY, USA 0, 0.5, 1 and 2 μg/kg/min, each infusion step for 5 minutes, total infusion period of 20 minutes
Nipruss®, Sanol-Schwarz, Monheim, Germany 0, 0.5, 1 and 2 µg/kg/min, each infusion step for 5 minutes, total infusion period of 20 minutes
experimental stepwise increase of intraocular pressure while measurement of choroidal thickness suction force of 25, 50, 75, and 100 mmH
안압 측정
Optical coherence tomography is a widely used non-invasive method to image the retina and choroid.
Using a 1060nm light source coupled to a commercially available OCT system (Heidelberg Engineering, Heidelberg, Germany) allows for the measurement of choroidal thickness
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Choroidal thickness
기간: 18 months
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18 months
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2차 결과 측정
결과 측정 |
기간 |
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Systolic/diastolic blood pressure (non-invasive)
기간: 18 months
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18 months
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Intraocular pressure (IOP)
기간: 18 months
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18 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Gerhard Garhöfer, MD, PD, Department of Clinical Pharmacology, Medical University of Vienna
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- OPHT-151010
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Phenylephrine에 대한 임상 시험
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