Thinking of joining a study?

Register your interest

NCT05130385 | Recruiting | Retinal Disease


High Resolution Optical Coherence Tomography
Sponsor:

Insel Group AG, University Hospital Bern

Brief Summary:

Comparison of high-resolution optical coherence tomography (High-Res-OCT) to conventional imaging modalities for the diagnosis of eye diseases

Condition or disease

Retinal Disease

Retinal Detachment

Retinal Vein Occlusion

Retinal Dystrophy

Retinal Artery Occlusion

Retinal Edema

Retinal Neovascularization

Uveitis

Diabetic Retinopathy

Diabetic Macular Edema

Macular Edema

Macular Degeneration

Macular Disease

Glaucoma

Optic Nerve Diseases

Hypertensive Retinopathy

Intervention/treatment

High-resolution optical coherence tomography (High-Res-OCT)

Standard spectral domain OCT (SD-OCT)

Detailed Description:

The high resolution optical coherence tomography (High-Res-OCT) is an improvement of a non-invasive routinely used imaging technique, the optical coherence tomography (OCT), with a light-source capable of providing an increased axial resolution. The routinely used Spectral-Domain OCT has a center wavelength of 880 nm and a spectral bandwidth of 40 nm, resulting in an axial resolution of approximately 7 μm in the eye and is used routinely worldwide. The High-Res OCT works with a central wavelength of 840 nm and an increased bandwidth of 130 nm, making it possible to improve the optical axial resolution in tissue from 7 to 3 µm, without increasing the maximum laser exposure limit. The improved axial resolution of the High-Res OCT results in clearer and more detailed images. The technique is routinely used in clinical practice and the device used for High-Res-OCT (Heidelberg, SPECTRALIS® High-Res OCT- DMR001) has received CE mark (european conformity in the extended Single Market in the European Economic Area) approval in March 2021. We plan to compare High-Res-OCT as an imaging modality to conventional imaging modalities used in clinical routine, such as the Spectral-Domain-OCT (SD-OCT)}}

Study Type : Observational
Estimated Enrollment : 550 participants
Official Title : Investigation of Retinal Pathology in Eye Diseases Using High Resolution Optical Coherence Tomography (High-Res-OCT)
Actual Study Start Date : November 30, 2021
Estimated Primary Completion Date : November 30, 2023
Estimated Study Completion Date : November 30, 2023

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Accepts Healthy Volunteers
Criteria
Inclusion Criteria
  • Patients from the Department of Ophthalmology, University Hospital Bern requiring conventional imaging for eye disease and willing to sign informed consent Patients of 18 years or older
Exclusion Criteria
  • Patients not willing or able to sign informed consent
  • Patients younger than 18 years
  • Patients with epilepsy.
  • Vulnerable subjects (except the objectives of the investigation concern vulnerable subjects specifically),
  • Inability to follow the procedures of the investigation, e.g. due to language problems, psychological disorders, dementia, etc. of the subject
  • Participation in another investigation with an investigational drug or another MD within the 30 days preceding and during the present investigation
  • Enrolment of the PI, his/her family members, employees and other dependent persons

High Resolution Optical Coherence Tomography

Location Details


Please Choose a site



High Resolution Optical Coherence Tomography

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Recruiting

Switzerland, Bern

Department of Ophthalmology, Bern University Hospital, Bern, 3010 Bern, Switzerland

Bern 3010, Bern, Switzerland, 3010

Loading...