Assessment of Scan Quality of Sparse OCT Retina Scanner (MimoStudy01)
1 other identifier
interventional
30
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2015
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 17, 2015
CompletedFirst Posted
Study publicly available on registry
September 22, 2015
CompletedStudy Start
First participant enrolled
November 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedFebruary 24, 2016
February 1, 2016
2 months
September 17, 2015
February 23, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
During diagnostic intervention, expected to be ca. 30 minutes on average
Secondary Outcomes (2)
Patient comfort during examination
Directly after diagnostic intervention, expected to be ca. 35 minutes on average
Duration of OCT examination with investigational device
Directly after diagnostic intervention, expected to be ca. 35 minutes on average
Study Arms (1)
All study participants
EXPERIMENTALPatient's eyes are OCT-scanned with standard device and investigational device.
Interventions
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
Eligibility Criteria
You may qualify if:
- years or older
- German speaking
- Suffering from age-related macular degeneration
- Written informed consent
You may not qualify if:
- Epilepsy
- Parkinsonian syndrome
- Dementia
- Pregnant women
- Persons using electronic medical aids i.e. hearing aid, pacemaker..
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Bernlead
- University Hospital, Zürichcollaborator
- ISS AGcollaborator
Study Sites (1)
Augenklinik Univestitätspital Zürich
Zurich, Canton of Zurich, 8006, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sandrine Zweifel, MD
Augenklinik Universitätspital Zürich
- STUDY DIRECTOR
Raphael Sznitman
ARTORG, University of Bern
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 17, 2015
First Posted
September 22, 2015
Study Start
November 1, 2015
Primary Completion
January 1, 2016
Study Completion
January 1, 2016
Last Updated
February 24, 2016
Record last verified: 2016-02