Assessment of Scan Quality of Sparse OCT Retina Scanner (MimoStudy01)
Optical Coherence Tomography (OCT) is an established non-invasive medical imaging technique ophthalmologists use to diagnose and monitor retinal diseases such as age-related macular degeneration (AMD).
This study assesses the scanning performance of a newly developed sparse OCT retina scanner that is smaller and more compact than most commercially available medical OCT systems. The prototype device was developed at Artorg Center Bern and Berner Fachhochschule Biel.
In this study the device is first tested on human eyes. The scanning performance is compared to a reference device. Additionally patient feedback during the examination is acquired.
The findings of this study are used to improve the software and the ergonomics of the investigational device.
연구 개요
상세 설명
Background
Optical Coherence Tomography (OCT) is an established non-invasive medical imaging technique ophthalmologists use to diagnose and monitor retinal diseases such as age-related macular degeneration (AMD).
This study assesses the scanning performance of a newly developed sparse OCT retina scanner that is smaller and more compact than most commercially available medical OCT systems. The prototype device was developed at Artorg Center Bern and Berner Fachhochschule Biel.
In this study the device is first tested on human eyes. The scanning performance is compared to a reference device. Additionally patient feedback during the examination is acquired.
The findings of this study are used to improve the software and the ergonomics of the investigational device.
Objective
- Comparing scan quality of investigational device to scan quality of reference device.
- Obtaining patient feedback on the examination with investigational device.
Methods
Comparison of OCT scans made with standard device and investigational device.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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ZH
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Zürich, ZH, 스위스, 8006
- Augenklinik Univestitätspital Zürich
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- 18 years or older
- German speaking
- Suffering from age-related macular degeneration
- Written informed consent
Exclusion Criteria
- Epilepsy
- Parkinsonian syndrome
- Dementia
- Pregnant women
- Persons using electronic medical aids i.e. hearing aid, pacemaker..
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: All study participants
Patient's eyes are OCT-scanned with standard device and investigational device.
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OCT scan (as yet unnamed) of the eye with investigational device; newly developed sparse OCT retina scanner by Artorg Center Bern and Berner Fachhochschule Biel
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Distance between ILM and RPE (IPD) measurement successful or not. Successful is defined as a) measurement performed/failed, and if performed, b) value obtained within ±10% of value of reference OCT device.
기간: During diagnostic intervention, expected to be ca. 30 minutes on average
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During diagnostic intervention, expected to be ca. 30 minutes on average
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Patient comfort during examination
기간: Directly after diagnostic intervention, expected to be ca. 35 minutes on average
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Assessed via interview with patient
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Directly after diagnostic intervention, expected to be ca. 35 minutes on average
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Duration of OCT examination with investigational device
기간: Directly after diagnostic intervention, expected to be ca. 35 minutes on average
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Directly after diagnostic intervention, expected to be ca. 35 minutes on average
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공동 작업자 및 조사자
수사관
- 수석 연구원: Sandrine Zweifel, MD, Augenklinik Universitätspital Zürich
- 연구 책임자: Raphael Sznitman, ARTORG, University of Bern
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 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 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. .
OCT scan (as yet unnamed)에 대한 임상 시험
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Institute of Child HealthGreat Ormond Street Hospital for Children NHS Foundation Trust아직 모집하지 않음
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Northwestern University종료됨