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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02555995

Enrollment

Registered

2015-09-22

Start date

2015-11-30

Completion date

2016-01-31

Last updated

2016-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Macular Degeneration

Keywords

AMD, OCT

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.

Interventions

DEVICEOCT scan (as yet unnamed)

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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..

Design outcomes

Primary

Measure	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

Measure	Time frame	Description
Patient comfort during examination	Directly after diagnostic intervention, expected to be ca. 35 minutes on average	Assessed via interview with patient
Duration of OCT examination with investigational device	Directly after diagnostic intervention, expected to be ca. 35 minutes on average	—

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026