A Pilot Study for the Evaluation of the Safety and Performance of a Combined OCT System (Hydra01)

A Prospective,Open Label,Non-randomized,Single-centre,Exploratory,Stratified Pilot Study for the Evaluation of the Safety and Performance of a Combined Coaxial Optical Coherence Tomography (OCT) System,to Image Diseases of the Posterior and Anterior Segment of the Eye

The novel Coaxial Optical Coherence Tomography (OCT) System is designed to visualize both structures of the retina and choroid.

The purpose of this research is the safety and evaluation of a combined coaxial optical coherence tomography (OCT) system, to image diseases of the posterior and anterior segment of the eye.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Device: combined Coaxial Optical Coherence Tomography (OCT) System

Detailed Description

Background and Rationale:

Many posterior segment ocular diseases involve the retinal and choroidal vasculature. A new technology to noninvasively and simultaneously visualize vascular pathology is of utmost importance to reduce patient exposure to different diagnosis methods like e.g. fluorescence angiography. The novel Coaxial Optical Coherence Tomography (OCT) System is designed to visualize both structures of the retina and choroid.

Furthermore, it may be used to image other structures of the eye.

Objective(s):

The purpose of this research is the safety and evaluation of a combined coaxial optical coherence tomography (OCT) system, to image diseases of the posterior and anterior segment of the eye. This device may be useful for the early diagnosis and monitoring of a variety of diseases involving the eye, such as Glaucoma, Diabetic Retinopathy or Age-Related Macular Degeneration. Measurements are compared to normal controls.

Measurements and procedures:

After screening, all participants will undergo a scanning procedure on the same day.

Only one eye of each participant will be scanned with the investigational device. For patients, the eye showing the disease will be chosen, for healthy volunteers, the left or right eye will be scanned according to a randomisation list.

The image quality is rated by the investigator and an independent assessor on a VAS (visual analogue scale). A subgroup of each stratum will have a comparative measurement of the choroid thickness against a SS-OCT (swept-source-OCT) device (Topcon) and a retina thickness against the Spectralis data. The subgroup will consist of half planned sample size. The measurement is taken from one eye, ie. every second participant per stratum will be attributed to the thickness measurement subgroup. The endpoint is a true/false criterion on whether the measurement of the retina and choroid thickness was successful. The thickness is measured in μm. The measurement is considered a "success" if the value is no more than +/- 10% off the reference measurement.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects with healthy eye, or has been diagnosed already with eye disease
• Patients > 18 years of age
• Informed Consent as documented by date and signature

Exclusion Criteria:

• Clinically significant concomitant disease that impair measurement
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, late stage Alzheimer disease, etc. of the participant,
• Subjects using implanted electronic medical devices (e.g. cochlear implant, pacemaker, defibrillator, infusion pump).
• Participation in another study with investigational drug within the 30 days preceding and during the present study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Healthy subjects; One eye of each participant will be scanned with the investigational device (= combined Coaxial Optical Coherence Tomography (OCT) System)	Device: combined Coaxial Optical Coherence Tomography (OCT) System; The investigational device is an OCT scanner prototype with two different wavelengths developed based on a CE marked OCT device (Spectralis® Heidelberg) at the Berner Fachhochschule, Biel
Other: Diseased groups; lf one eye is affected, this will be chosen. lf both eyes are be affected, the eye with the severest symptoms will be chosen. Scanning with the investigational device (= combined Coaxial Optical Coherence Tomography (OCT) System)	Device: combined Coaxial Optical Coherence Tomography (OCT) System; The investigational device is an OCT scanner prototype with two different wavelengths developed based on a CE marked OCT device (Spectralis® Heidelberg) at the Berner Fachhochschule, Biel
Other: Diseased subgroups; Every second subject will be allocated to the subgroup.; Scanning with the investigational device (= combined Coaxial Optical Coherence Tomography (OCT) System); Thickness measurement with reference medical device.	Device: combined Coaxial Optical Coherence Tomography (OCT) System; The investigational device is an OCT scanner prototype with two different wavelengths developed based on a CE marked OCT device (Spectralis® Heidelberg) at the Berner Fachhochschule, Biel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual acuity (VA) after investigation	Safety of the imaging investigation expressed as visual acuity before (baseline) and after imaging, and tolerability assessment questionnaire.	Within 1 hour after investigation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scan quality	Comparing scan quality of investigational device to scan quality of a reference device, expressed as thickness of the retina and the thickness of the choroid	After completion of all measurement, an average of 2 years.
Procedural success	Procedural success that is defined as: Image Quality of anterior and posterior eye structures	After completion of all measurement, an average of 2 years.
Procedural safety and comfort assessed by questionnaire	Procedural comfort in the opinion of the patients assessed with a questionnaire	Within 1 hour after investigation

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Study Director: Hendrik PN Scholl, MD, University Hospital Basel, Dept. of Ophthalmology; Principal Investigator: Pascal Hasler, MD, University Hospital Basel, Dept. of Ophthalmology

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: November 17, 2017
• First Submitted That Met QC Criteria: January 25, 2018
• First Posted (Actual): February 5, 2018

Study Record Updates

• Last Update Posted (Actual): April 1, 2020
• Last Update Submitted That Met QC Criteria: March 31, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Hydra01
• Other Study ID Numbers: 085-HAP-2017-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No