Clinical trial NCT02555995: Assessment of Scan Quality of Sparse OCT Retina Scanner (MimoStudy01)
Official title: Assessment of Scan Quality of Sparse OCT Retina Scanner (MimoStudy01)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Macular Degeneration
Keywords: AMD
OCT
Lead sponsor: University of Bern
Sponsor class: OTHER
Collaborators: name: University Hospital, Zürich
name: ISS AG
First posted: 2015-09-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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..

Primary outcomes:
measure: 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.
timeFrame: During diagnostic intervention, expected to be ca. 30 minutes on average
Secondary outcomes:
measure: Patient comfort during examination
timeFrame: Directly after diagnostic intervention, expected to be ca. 35 minutes on average
measure: Duration of OCT examination with investigational device
timeFrame: Directly after diagnostic intervention, expected to be ca. 35 minutes on average
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Augenklinik Univestitätspital Zürich
state: ZH
Study officials:
affiliation: Augenklinik Universitätspital Zürich
name: Sandrine Zweifel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: ARTORG, University of Bern
name: Raphael Sznitman
role: STUDY_DIRECTOR
References: