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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 30
- Primary Endpoint
- Visual acuity (VA) after investigation
Study Overview
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 coaxial optical coherence tomography (OCT) system, to image diseases of the posterior and anterior segment of the eye.
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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Visual acuity (VA) after investigation
Time Frame: Within 1 hour after investigation
Safety of the imaging investigation expressed as visual acuity before (baseline) and after imaging, and tolerability assessment questionnaire.
Secondary Outcomes
- Procedural safety and comfort assessed by questionnaire(Within 1 hour after investigation)
- Procedural success(After completion of all measurement, an average of 2 years.)
- Scan quality(After completion of all measurement, an average of 2 years.)