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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Device: combined Coaxial Optical Coherence Tomography (OCT) System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Proof of concept study, medical device investigation
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Healthy subjects<br>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<br>* 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<br>|
| Other: Diseased groups<br>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<br>* 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<br>|
| Other: Diseased subgroups<br>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<br>* 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<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hydra01