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

NCT03419390 | Completed

• 1 other identifier: 085-HAP-2017-001
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy

Keywords

Hydra01

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Scan quality

  After completion of all measurement, an average of 2 years.

• Procedural success

  After completion of all measurement, an average of 2 years.

• Procedural safety and comfort assessed by questionnaire

  Within 1 hour after investigation

Study Arms (3)

Healthy subjects

OTHER

One eye of each participant will be scanned with the investigational device (= combined Coaxial Optical Coherence Tomography (OCT) System)

Device: combined Coaxial Optical Coherence Tomography (OCT) System

Diseased groups

OTHER

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)

Device: combined Coaxial Optical Coherence Tomography (OCT) System

Diseased subgroups

OTHER

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.

Device: combined Coaxial Optical Coherence Tomography (OCT) System

Interventions

combined Coaxial Optical Coherence Tomography (OCT) System DEVICE

The investigational device is an OCT scanner prototype with two different wavelengths developed based on a CE marked OCT device (Spectralis® Heidelberg) at the Berner Fachhochschule, Biel

Diseased groups; Diseased subgroups; Healthy subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

MeSH Terms

Interventions

Tomography, Optical Coherence; Drug Delivery Systems

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques; Drug Therapy; Therapeutics

Study Officials

• Hendrik PN Scholl, MD

  University Hospital Basel, Dept. of Ophthalmology

  STUDY DIRECTOR

• Pascal Hasler, MD

  University Hospital Basel, Dept. of Ophthalmology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Proof of concept study, medical device investigation

Study Record Dates

• First Submitted: November 17, 2017
• First Posted: February 5, 2018
• Study Start: December 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: December 1, 2019
• Last Updated: April 1, 2020

Record last verified: 2020-03