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NCT Number: NCT02555995

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

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.

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Key information

Conditions

Macular Degeneration Eye Diseases Retinal Degeneration Retinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Augenklinik Univestitätspital Zürich

Zurich, Canton of Zurich, 8006, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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..

Treatment and study plan

OCT scan (as yet unnamed)

Device

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

Primary outcomes

  1. 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.

    Time frame: During diagnostic intervention, expected to be ca. 30 minutes on average

Secondary outcomes

  1. Patient comfort during examination

    Time frame: Directly after diagnostic intervention, expected to be ca. 35 minutes on average

    Assessed via interview with patient

  2. Duration of OCT examination with investigational device

    Time frame: Directly after diagnostic intervention, expected to be ca. 35 minutes on average

Sponsors and collaborators

Lead sponsor

University of Bern

Other

Collaborators

  • ISS AG
  • University Hospital, Zürich

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 22, 2015
Registry last updated
Feb 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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