Assessment of Scan Quality of Sparse OCT Retina Scanner (MimoStudy01)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Bern
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18 years or older
- •German speaking
- •Suffering from age-related macular degeneration
- •Written informed consent
Exclusion Criteria
- •Parkinsonian syndrome
- •Pregnant women
- •Persons using electronic medical aids i.e. hearing aid, pacemaker..
Arms & Interventions
All study participants
Patient's eyes are OCT-scanned with standard device and investigational device.
Intervention: OCT scan (as yet unnamed) (Device)
Outcomes
Primary Outcomes
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.
Time Frame: During diagnostic intervention, expected to be ca. 30 minutes on average
Secondary Outcomes
- 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)