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

Not Applicable

Completed

• Conditions: Macular Degeneration
• Interventions: Device: OCT scan (as yet unnamed)

• Registration Number: NCT02555995
• Lead Sponsor: University of Bern

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.

Study Timeline

• Study First Submitted: 2015-09-17
• Study First Submitted QC: 2015-09-21
• Study First Posted: 2015-09-22
• Study Start: 2015-11
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-23
• Last Update Posted: 2016-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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..

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All study participants	OCT scan (as yet unnamed)	Patient's eyes are OCT-scanned with standard device and investigational device.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Augenklinik Univestitätspital Zürich; 🇨🇭 Zürich, ZH, Switzerland