High Resolution Optical Coherence Tomography

Sponsor

University Hospital Inselspital, Berne (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05130385

Collaborator

(none)

550

Enrollment

Location

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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	Device: High-resolution optical coherence tomography (High-Res-OCT) Device: 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 Design

Study Type:

Observational

Anticipated Enrollment :

550 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Sep 30, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Diabetic Retinopathy Patients with various degree of diabetic retinopathy	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
Artery and vein occlusion Patients with history of artery or vein occlusion (central or branch artery)	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
Glaucoma Patients with history of glaucoma (open-angle glaucoma, chronic angle closure glaucoma)	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
Optic nerve neuropathy Patients with history of various optic nerve neuropathies	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
Hereditary retinal diseases Patients with history of various retinal dystrophies	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
Retinal detachment Patients history of retinal detachment	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
Age related macular degeneration Patients with history of age related macular degeneration	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
Retinal changes from arterial hypertension Patients with history of arterial hypertension	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
Uveitis Patients with history of uveitis intermedia and/or posterior and/or pan-uveitis	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
Healthy Healthy age matched control subjects	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

Outcome Measures

Primary Outcome Measures

Evaluation of the sensitivity and specificity of High-Res-OCT for retinal fluid [2 years]
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)

Secondary Outcome Measures

Evaluation of the sensitivity and specificity of High-Res-OCT for atrophy area [2 years]
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)
Evaluation of the sensitivity and specificity of High-Res-OCT for epiretinal membrane [2 years]
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)
Evaluation of the sensitivity and specificity of High-Res-OCT for drusen [2 years]
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).
Evaluation of the sensitivity and specificity of High-Res-OCT for ischemia [2 years]
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.
Evaluation of the sensitivity and specificity of High-Res-OCT for neovascularisation [2 years]
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.
Evaluation of the sensitivity and specificity of High-Res-OCT for optic disc swelling [2 years]
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).
Evaluation of the sensitivity and specificity of High-Res-OCT for hyperreflective foci [2 years]
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.
Evaluation of the sensitivity and specificity of High-Res-OCT for scars [2 years]
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.
Evaluation of the inter-reader reproducibility [2 years]
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).
Subgroup analysis [2 years]
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.
Evaluation of the segmentation quality of the retinal layers using High-Res-OCT [2 years]
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.

Other Outcome Measures

Correlation of pathological changes with fundus color photographs [2 years]
Evaluation whether pathological changes seen in color fundus photography correlate with changes seen in High-Res-OCT. Here, a binary readout, i.e pathology present (yes/no) will be used.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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