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

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University Hospital Basel

Status

Completed

Conditions

Healthy

Treatments

Device: combined Coaxial Optical Coherence Tomography (OCT) System

Study type

Interventional

Funder types

Other

Identifiers

NCT03419390
085-HAP-2017-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 3 patient groups

Healthy subjects
Other group
Description:
One eye of each participant will be scanned with the investigational device (= combined Coaxial Optical Coherence Tomography (OCT) System)
Treatment:
Device: combined Coaxial Optical Coherence Tomography (OCT) System
Diseased groups
Other group
Description:
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)
Treatment:
Device: combined Coaxial Optical Coherence Tomography (OCT) System
Diseased subgroups
Other group
Description:
Every second subject will be allocated to the subgroup. 1. Scanning with the investigational device (= combined Coaxial Optical Coherence Tomography (OCT) System) 2. Thickness measurement with reference medical device.
Treatment:
Device: combined Coaxial Optical Coherence Tomography (OCT) System

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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