Healthy Clinical Trial
Official 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
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.
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.
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