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

Primary Purpose

Macular Degeneration

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
OCT scan (as yet unnamed)
Sponsored by
University of Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Macular Degeneration focused on measuring AMD, OCT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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..

Sites / Locations

  • Augenklinik Univestitätspital Zürich

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All study participants

Arm Description

Patient's eyes are OCT-scanned with standard device and investigational device.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Patient comfort during examination
Assessed via interview with patient
Duration of OCT examination with investigational device

Full Information

First Posted
September 17, 2015
Last Updated
February 23, 2016
Sponsor
University of Bern
Collaborators
University Hospital, Zürich, ISS AG
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1. Study Identification

Unique Protocol Identification Number
NCT02555995
Brief Title
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

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Bern
Collaborators
University Hospital, Zürich, ISS AG

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Degeneration
Keywords
AMD, OCT

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
All study participants
Arm Type
Experimental
Arm Description
Patient's eyes are OCT-scanned with standard device and investigational device.
Intervention Type
Device
Intervention Name(s)
OCT scan (as yet unnamed)
Intervention Description
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 Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Patient comfort during examination
Description
Assessed via interview with patient
Time Frame
Directly after diagnostic intervention, expected to be ca. 35 minutes on average
Title
Duration of OCT examination with investigational device
Time Frame
Directly after diagnostic intervention, expected to be ca. 35 minutes on average

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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..
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandrine Zweifel, MD
Organizational Affiliation
Augenklinik Universitätspital Zürich
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Raphael Sznitman
Organizational Affiliation
ARTORG, University of Bern
Official's Role
Study Director
Facility Information:
Facility Name
Augenklinik Univestitätspital Zürich
City
Zürich
State/Province
ZH
ZIP/Postal Code
8006
Country
Switzerland

12. IPD Sharing Statement

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

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