Trials / Unknown
UnknownNCT05130385
High Resolution Optical Coherence Tomography
Investigation of Retinal Pathology in Eye Diseases Using High Resolution Optical Coherence Tomography (High-Res-OCT)
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 550 (estimated)
- Sponsor
- Insel Gruppe AG, University Hospital Bern · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
Comparison of high-resolution optical coherence tomography (High-Res-OCT) to conventional imaging modalities for the diagnosis of eye diseases
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)
Conditions
- 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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | High-resolution optical coherence tomography (High-Res-OCT) | Imaging with high-resolution optical coherence tomography |
| DEVICE | Standard spectral domain OCT (SD-OCT) | Imaging with standard spectral domain OCT |
Timeline
- Start date
- 2021-11-30
- Primary completion
- 2023-11-30
- Completion
- 2023-11-30
- First posted
- 2021-11-23
- Last updated
- 2022-11-29
Locations
1 site across 1 country: Switzerland
Source: ClinicalTrials.gov record NCT05130385. Inclusion in this directory is not an endorsement.