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

NCT ID: NCT02555995

Last Updated: 2016-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2016-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Macular Degeneration

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

All study participants

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

Group Type EXPERIMENTAL

OCT scan (as yet unnamed)

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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..
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Zürich

OTHER

Sponsor Role collaborator

ISS AG

UNKNOWN

Sponsor Role collaborator

University of Bern

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sandrine Zweifel, MD

Role: PRINCIPAL_INVESTIGATOR

Augenklinik Universitätspital Zürich

Raphael Sznitman

Role: STUDY_DIRECTOR

ARTORG, University of Bern

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Augenklinik Univestitätspital Zürich

Zurich, Canton of Zurich, Switzerland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KEK-ZH-Nr. 2015-0316

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The Spectralis-Cirrus Study
NCT00927303 COMPLETED