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

University of Bern

Status: Completed

Conditions: Macular Degeneration

Treatments: Device: OCT scan (as yet unnamed)

Study type: Interventional

Funder types: Other

Identifiers

NCT02555995

KEK-ZH-Nr. 2015-0316

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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..

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

30 participants in 1 patient group

All study participants

Experimental group

Description:

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

Treatment:

Device: OCT scan (as yet unnamed)