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

Macular Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02555995
• Other study ID #: KEK-ZH-Nr. 2015-0316
• Status: Completed
• Phase: N/A
• First received: September 17, 2015
• Last updated: February 23, 2016
• Start date: November 2015
• Est. completion date: January 2016

Study information

• Verified date: February 2016
• Source: University of Bern
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: EthikkommissionSwitzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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..

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Macular Degeneration

Intervention

Device:
• OCT 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

Locations

Country	Name	City	State
Switzerland	Augenklinik Univestitätspital Zürich	Zürich	ZH

Sponsors (3)

Lead Sponsor	Collaborator
University of Bern	ISS AG, University Hospital, Zürich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Patient comfort during examination	Assessed via interview with patient	Directly after diagnostic intervention, expected to be ca. 35 minutes on average	No
Secondary	Duration of OCT examination with investigational device		Directly after diagnostic intervention, expected to be ca. 35 minutes on average	No