A Pilot Study for the Evaluation of the Safety and Performance of a Combined OCT System (Hydra01)
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Annen: Healthy subjects
One eye of each participant will be scanned with the investigational device (= combined Coaxial Optical Coherence Tomography (OCT) System)
|
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
|
|
Annen: Diseased groups
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)
|
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
|
|
Annen: Diseased subgroups
Every second subject will be allocated to the subgroup.
|
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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Visual acuity (VA) after investigation
Tidsramme: Within 1 hour 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Scan quality
Tidsramme: After completion of all measurement, an average of 2 years.
|
Comparing scan quality of investigational device to scan quality of a reference device, expressed as thickness of the retina and the thickness of the choroid
|
After completion of all measurement, an average of 2 years.
|
|
Procedural success
Tidsramme: After completion of all measurement, an average of 2 years.
|
Procedural success that is defined as: Image Quality of anterior and posterior eye structures
|
After completion of all measurement, an average of 2 years.
|
|
Procedural safety and comfort assessed by questionnaire
Tidsramme: Within 1 hour after investigation
|
Procedural comfort in the opinion of the patients assessed with a questionnaire
|
Within 1 hour after investigation
|
Samarbeidspartnere og etterforskere
Etterforskere
- Studieleder: Hendrik PN Scholl, MD, University Hospital Basel, Dept. of Ophthalmology
- Hovedetterforsker: Pascal Hasler, MD, University Hospital Basel, Dept. of Ophthalmology
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 085-HAP-2017-001
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Sunn
-
Universidad Católica del MauleRekruttering
-
Universidad Católica del MauleFullført
-
Universidade do PortoFoundation for Science and Technology (FCT); Faculdade de Desporto da Universidade...Aktiv, ikke rekrutterendeHealthy People-programmerPortugal
-
VA Office of Research and DevelopmentFullført
-
University Rovira i VirgiliFullførtHealthy People-programmer | Forebygging og kontrollSpania
-
Universidade do PortoFoundation for Science and Technology, PortugalAktiv, ikke rekrutterende
-
University Hospital, GhentRekrutteringHealthy Controls Group - alders- og kjønnsmatchet | Repeterende negativ tenkningBelgia
-
University of MiamiJames and Esther King Biomedical Research ProgramAvsluttetHealthy Lifetime Ikke-røykereForente stater
-
Fundació Institut de Recerca de l'Hospital de la...FullførtHealthy People-programmerSpania
-
University of North Carolina, Chapel HillNorth Carolina Translational and Clinical Sciences InstituteRekrutteringHealthy Controls Group - alders- og kjønnsmatchet | Borderline personlighetsforstyrrelse (BPD)Forente stater
Kliniske studier på combined Coaxial Optical Coherence Tomography (OCT) System
-
University of PalermoRekrutteringOral sykdom | Munnkreft | Aktiniske keratoser | Oral leukoplaki | Oral plateepitelkarsinom | Oral Lichen Planus | Graft-versus-vert-sykdom | Proliferativ Verrucous Leukoplakia | Aktinisk Cheilitt | Oral potensielt ondartet lidelse | Oral erytroplaki | Oral lichenoid lesjonItalia
-
Institute of Molecular and Clinical Ophthalmology...Institute of Molecular and Clinical Ophthalmology BaselRekrutteringNetthinnedystrofierForente stater, Sveits, Kina, Tyskland, Ungarn, Italia, Storbritannia
-
Fondation Ophtalmologique Adolphe de RothschildFullført
-
Cairo UniversityHar ikke rekruttert ennå
-
Centre Hospitalier National d'Ophtalmologie des...RekrutteringGlaukom assosiert med andre okulære lidelserFrankrike
-
Notal Vision Ltd.Elman Retina GroupFullførtDiabetisk makulært ødem | AMD – Aldersrelatert makuladegenerasjonForente stater
-
Medical University of ViennaRekruttering
-
Second Affiliated Hospital, School of Medicine,...Rekruttering
-
Medical University of ViennaFullførtFremre iskemisk optisk nevropatiØsterrike
-
Duke UniversityRekrutteringSS-HH-OCT som en ny diagnostisk modalitet for tidlig oppstått retinal dystrofier (EORDs) (SS-HH-OCT)NetthinnedystrofierForente stater