High Resolution Optical Coherence Tomography

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

Detailed Description
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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)

Official Title
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Investigation of Retinal Pathology in Eye Diseases Using High Resolution Optical Coherence Tomography (High-Res-OCT)

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diabetic Retinopathy<br>Patients with various degree of diabetic retinopathy | Device: High-resolution optical coherence tomography (High-Res-OCT)<br>* Imaging with high-resolution optical coherence tomography<br>Device: Standard spectral domain OCT (SD-OCT)<br>* Imaging with standard spectral domain OCT<br>|
| Artery and vein occlusion<br>Patients with history of artery or vein occlusion (central or branch artery) | Device: High-resolution optical coherence tomography (High-Res-OCT)<br>* Imaging with high-resolution optical coherence tomography<br>Device: Standard spectral domain OCT (SD-OCT)<br>* Imaging with standard spectral domain OCT<br>|
| Glaucoma<br>Patients with history of glaucoma (open-angle glaucoma, chronic angle closure glaucoma) | Device: High-resolution optical coherence tomography (High-Res-OCT)<br>* Imaging with high-resolution optical coherence tomography<br>Device: Standard spectral domain OCT (SD-OCT)<br>* Imaging with standard spectral domain OCT<br>|
| Optic nerve neuropathy<br>Patients with history of various optic nerve neuropathies | Device: High-resolution optical coherence tomography (High-Res-OCT)<br>* Imaging with high-resolution optical coherence tomography<br>Device: Standard spectral domain OCT (SD-OCT)<br>* Imaging with standard spectral domain OCT<br>|
| Hereditary retinal diseases<br>Patients with history of various retinal dystrophies | Device: High-resolution optical coherence tomography (High-Res-OCT)<br>* Imaging with high-resolution optical coherence tomography<br>Device: Standard spectral domain OCT (SD-OCT)<br>* Imaging with standard spectral domain OCT<br>|
| Retinal detachment<br>Patients history of retinal detachment | Device: High-resolution optical coherence tomography (High-Res-OCT)<br>* Imaging with high-resolution optical coherence tomography<br>Device: Standard spectral domain OCT (SD-OCT)<br>* Imaging with standard spectral domain OCT<br>|
| Age related macular degeneration<br>Patients with history of age related macular degeneration | Device: High-resolution optical coherence tomography (High-Res-OCT)<br>* Imaging with high-resolution optical coherence tomography<br>Device: Standard spectral domain OCT (SD-OCT)<br>* Imaging with standard spectral domain OCT<br>|
| Retinal changes from arterial hypertension<br>Patients with history of arterial hypertension | Device: High-resolution optical coherence tomography (High-Res-OCT)<br>* Imaging with high-resolution optical coherence tomography<br>Device: Standard spectral domain OCT (SD-OCT)<br>* Imaging with standard spectral domain OCT<br>|
| Uveitis<br>Patients with history of uveitis intermedia and/or posterior and/or pan-uveitis | Device: High-resolution optical coherence tomography (High-Res-OCT)<br>* Imaging with high-resolution optical coherence tomography<br>Device: Standard spectral domain OCT (SD-OCT)<br>* Imaging with standard spectral domain OCT<br>|
| Healthy<br>Healthy age matched control subjects | Device: High-resolution optical coherence tomography (High-Res-OCT)<br>* Imaging with high-resolution optical coherence tomography<br>Device: Standard spectral domain OCT (SD-OCT)<br>* Imaging with standard spectral domain OCT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the sensitivity and specificity of High-Res-OCT for retinal fluid | The primary objective of this observational study is to evaluate the sensitivity and specificity to diagnose retinal morphological abnormalities with High-Resolution OCT compared to conventional imaging method (SD-OCT). The main parameter that will be assessed is the presence/absence of retinal fluid. The incidence (binary) of retinal fluid will be assessed in High-Resolution OCT and compared to conventional imaging method, such as standard-OCT (SD-OCT) | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the sensitivity and specificity of High-Res-OCT for atrophy area | The incidence (binary) of atrophy area, defined as hypertransmission due to loss of outer retinal layers within the choroidea, will be assessed in High-Resolution OCT and compared to conventional imaging method, such as standard-OCT (SD-OCT) | 2 years | 
| Evaluation of the sensitivity and specificity of High-Res-OCT for epiretinal membrane | The incidence (binary) of epiretinal membrane (defined as thickening of the retinal nerve fiber layer) will be assessed in High-Resolution OCT and compared to conventional imaging method, such as standard-OCT (SD-OCT) | 2 years | 
| Evaluation of the sensitivity and specificity of High-Res-OCT for drusen | The incidence (binary) of drusen will be assessed in High-Resolution OCT and compared to conventional imaging method, such as standard-OCT (SD-OCT). Drusen are defined as hyperfluorescent deposits between the RPE and Bruch's membrane (BM). May be hard (small hyperreflective deposits in the retina) and soft (larger with indistinct edges). | 2 years | 
| Evaluation of the sensitivity and specificity of High-Res-OCT for ischemia | The incidence (binary) of ischemia will be assessed in High-Resolution OCT and compared to conventional imaging method, such as standard-OCT (SD-OCT). Ischemia is defined as hyperreflective band located within/above the outer plexiform layer. | 2 years | 
| Evaluation of the sensitivity and specificity of High-Res-OCT for neovascularisation | The incidence (binary) of neovascularisation will be assessed in High-Resolution OCT and compared to conventional imaging method, such as standard-OCT (SD-OCT). Neovascularisation is defined as abnormal growth of vessels from the choroid to the retina through the BM. | 2 years | 
| Evaluation of the sensitivity and specificity of High-Res-OCT for optic disc swelling | The incidence (binary) of optic disc swelling will be assessed in High-Resolution OCT and compared to conventional imaging method, such as standard-OCT (SD-OCT). Optic disc swelling is defined as an elevation of the whole nerve head, measured as follows: max. horizontal extent in micrometer of the RNFL (3 mm diameter peripapillary). | 2 years | 
| Evaluation of the sensitivity and specificity of High-Res-OCT for hyperreflective foci | The incidence (binary) of hyperreflective foci will be assessed in High-Resolution OCT and compared to conventional imaging method, such as standard-OCT (SD-OCT). Hyperreflective foci are defined as intraretinal hyperreflective dots. | 2 years | 
| Evaluation of the sensitivity and specificity of High-Res-OCT for scars | The incidence (binary) of scars will be assessed in High-Resolution OCT and compared to conventional imaging method, such as standard-OCT (SD-OCT). Scars are defined as hyperreflective fibrous tissue, which obscures RPE and choroid. | 2 years | 
| Evaluation of the inter-reader reproducibility | Evaluation of the inter-reader reproducibility of the diagnosis of retinal diseases with High-Res-OCT. Inter-reader reproducibility will be estimated using the Bland-Altman method and the coefficient of repeatability (CoR). | 2 years | 
| Subgroup analysis | Subgroup analysis will be performed with patients suffering from diabetic retinopathy, artery and vein occlusion, retinal detachment, glaucoma, optic nerve neuropathy, hereditary retinal diseases, age related macular degeneration, retinal changes from arterial hypertension and uveitis. For this purpose, the presence/absence of each above-mentioned morphological abnormality will be assessed/measured in each subgroup and compared with the standard OCT. | 2 years | 
| Evaluation of the segmentation quality of the retinal layers using High-Res-OCT | For this purpose the discrimination capacity between the different retinal layers will be assessed, i.e. internal limiting membrane, retinal nerve fiber layer, ganglion cell layer, inner plexiform layer, inner nuclear layer, outer plexiform layer, outer nuclear layer, external limiting membrane, photoreceptor layers, retinal pigment epithelium, Bruch's membrane, choriocapillaris, choroidal stroma. For this purpose, a binary outcome will also result, which means that the ability to discriminate between the above-mentioned adjacent layers will be indicated by yes/no. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Optical Coherence Tomography, Diagnostic Techniques, Ophthalmological, High resolution optical coherence tomography