Assessment of Scan Quality of Sparse OCT Retina Scanner (MimoStudy01)

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. 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.

Official Title
-----------------
Assessment of Scan Quality of Sparse OCT Retina Scanner (MimoStudy01)

Conditions
-----------------
Macular Degeneration

Intervention / Treatment
-----------------
* Device: OCT scan (as yet unnamed)


Participation Criteria
=================
Eligibility Criteria
-----------------
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..

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All study participants<br>Patient's eyes are OCT-scanned with standard device and investigational device. | Device: OCT scan (as yet unnamed)<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient comfort during examination | Assessed via interview with patient | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AMD, OCT