Healthy Clinical Trial
— Hydra01Official title:
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
Verified date | March 2020 |
Source | University Hospital, Basel, Switzerland |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | December 2019 |
Est. primary completion date | March 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Basel, Switzerland |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | |
Secondary | 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. | |
Secondary | Procedural safety and comfort assessed by questionnaire | Procedural comfort in the opinion of the patients assessed with a questionnaire | Within 1 hour after investigation |
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