High Resolution Optical Coherence Tomography

Insel Gruppe AG, University Hospital Bern

Status: Enrolling

Conditions: Optic Nerve Diseases; Retinal Dystrophy; Retinal Neovascularization; Retinal Artery Occlusion; Retinal Detachment; Macular Edema; Macular Disease; Retinal Disease; Retinal Edema; Hypertensive Retinopathy; Uveitis; Macular Degeneration; Diabetic Macular Edema; Glaucoma; Retinal Vein Occlusion; Diabetic Retinopathy

Treatments: Device: Standard spectral domain OCT (SD-OCT); Device: High-resolution optical coherence tomography (High-Res-OCT)

Study type: Observational

Funder types: Other

Identifiers

NCT05130385

High Res OCT

2021-D0038 (Registry Identifier)

Details and patient eligibility

About

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

Full 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)

Enrollment: 550 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

550 participants in 10 patient groups

Diabetic Retinopathy

Description:

Patients with various degree of diabetic retinopathy

Treatment:

Device: Standard spectral domain OCT (SD-OCT)

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

Artery and vein occlusion

Description:

Patients with history of artery or vein occlusion (central or branch artery)

Treatment:

Device: Standard spectral domain OCT (SD-OCT)

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

Glaucoma

Description:

Patients with history of glaucoma (open-angle glaucoma, chronic angle closure glaucoma)

Treatment:

Device: Standard spectral domain OCT (SD-OCT)

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

Optic nerve neuropathy

Description:

Patients with history of various optic nerve neuropathies

Treatment:

Device: Standard spectral domain OCT (SD-OCT)

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

Hereditary retinal diseases

Description:

Patients with history of various retinal dystrophies

Treatment:

Device: Standard spectral domain OCT (SD-OCT)

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

Retinal detachment

Description:

Patients history of retinal detachment

Treatment:

Device: Standard spectral domain OCT (SD-OCT)

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

Age related macular degeneration

Description:

Patients with history of age related macular degeneration

Treatment:

Device: Standard spectral domain OCT (SD-OCT)

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

Retinal changes from arterial hypertension

Description:

Patients with history of arterial hypertension

Treatment:

Device: Standard spectral domain OCT (SD-OCT)

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

Uveitis

Description:

Patients with history of uveitis intermedia and/or posterior and/or pan-uveitis

Treatment:

Device: Standard spectral domain OCT (SD-OCT)

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

Healthy

Description:

Healthy age matched control subjects

Treatment:

Device: Standard spectral domain OCT (SD-OCT)

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