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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
ZH
-
Zürich, ZH, Suisse, 8006
- Augenklinik Univestitätspital Zürich
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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..
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
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.
Délai: During diagnostic intervention, expected to be ca. 30 minutes on average
|
During diagnostic intervention, expected to be ca. 30 minutes on average
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Patient comfort during examination
Délai: 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
Délai: Directly after diagnostic intervention, expected to be ca. 35 minutes on average
|
Directly after diagnostic intervention, expected to be ca. 35 minutes on average
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Sandrine Zweifel, MD, Augenklinik Universitätspital Zürich
- Directeur d'études: Raphael Sznitman, ARTORG, University of Bern
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- KEK-ZH-Nr. 2015-0316
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