Status:
COMPLETED
A Pilot Study for the Evaluation of the Safety and Performance of a Combined OCT System
Lead Sponsor:
University Hospital, Basel, Switzerland
Conditions:
Healthy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2019
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03419390
Start Date
December 1 2016
End Date
December 1 2019
Last Update
April 1 2020
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