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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
ZH
-
Zürich, ZH, Schweiz, 8006
- Augenklinik Univestitätspital Zürich
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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..
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: All study participants
Patient's eyes are OCT-scanned with standard device and investigational device.
|
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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
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.
Tidsramme: During diagnostic intervention, expected to be ca. 30 minutes on average
|
During diagnostic intervention, expected to be ca. 30 minutes on average
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Patient comfort during examination
Tidsramme: Directly after diagnostic intervention, expected to be ca. 35 minutes on average
|
Assessed via interview with patient
|
Directly after diagnostic intervention, expected to be ca. 35 minutes on average
|
|
Duration of OCT examination with investigational device
Tidsramme: Directly after diagnostic intervention, expected to be ca. 35 minutes on average
|
Directly after diagnostic intervention, expected to be ca. 35 minutes on average
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Sandrine Zweifel, MD, Augenklinik Universitätspital Zürich
- Studieleder: Raphael Sznitman, ARTORG, University of Bern
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- KEK-ZH-Nr. 2015-0316
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