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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-D0038 | Registry Identifier | Swiss National Clinical Trials Portal |
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Comparison of high-resolution optical coherence tomography (High-Res-OCT) to conventional imaging modalities for the diagnosis of eye diseases
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diabetic Retinopathy | Patients with various degree of diabetic retinopathy |
| |
| Artery and vein occlusion | Patients with history of artery or vein occlusion (central or branch artery) |
| |
| Glaucoma | Patients with history of glaucoma (open-angle glaucoma, chronic angle closure glaucoma) |
| |
| Optic nerve neuropathy | Patients with history of various optic nerve neuropathies |
| |
| Hereditary retinal diseases | Patients with history of various retinal dystrophies |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-resolution optical coherence tomography (High-Res-OCT) | Device | Imaging with high-resolution optical coherence tomography |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of pathological changes with fundus color photographs | 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. | 2 years |
Inclusion Criteria:
Exclusion Criteria:
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Participants with a history of clinically diagnosed ocular disorders, including but not limited to diabetic retinopathy, artery and vein occlusion, glaucoma, optic nerve neuropathy, hereditary retinal diseases/dystrophies, retinal detachment, age related macular degeneration, retinal changes from arterial hypertension, uveitis and healthy individuals undergoing ophthalmic Imaging in Routine clinical practice will be included
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Martin S Zinkernagel, MD, PhD | Contact | +41316329565 | martin.zinkernagel@insel.ch |
| Name | Affiliation | Role |
|---|---|---|
| Oussama Habra, MD | Department of Ophthalmology, University hospital Bern | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Ophthalmology, Bern University Hospital, Bern, 3010 Bern, Switzerland | Recruiting | Bern | Canton of Bern | 3010 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 1957169 | Background | Huang D, Swanson EA, Lin CP, Schuman JS, Stinson WG, Chang W, Hee MR, Flotte T, Gregory K, Puliafito CA, et al. Optical coherence tomography. Science. 1991 Nov 22;254(5035):1178-81. doi: 10.1126/science.1957169. | |
| 30560558 | Background | Ly A, Phu J, Katalinic P, Kalloniatis M. An evidence-based approach to the routine use of optical coherence tomography. Clin Exp Optom. 2019 May;102(3):242-259. doi: 10.1111/cxo.12847. Epub 2018 Dec 17. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 7, 2021 |
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| Retinal detachment | Patients history of retinal detachment |
|
| Age related macular degeneration | Patients with history of age related macular degeneration |
|
| Retinal changes from arterial hypertension | Patients with history of arterial hypertension |
|
| Uveitis | Patients with history of uveitis intermedia and/or posterior and/or pan-uveitis |
|
| Healthy | Healthy age matched control subjects |
|
| Standard spectral domain OCT (SD-OCT) | Device | Imaging with standard spectral domain OCT |
|
| 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 |
| 7804919 | Background | Guyatt G, Jaeschke R, Heddle N, Cook D, Shannon H, Walter S. Basic statistics for clinicians: 1. Hypothesis testing. CMAJ. 1995 Jan 1;152(1):27-32. |
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| 32091677 | Background | Bille JF, editor. High Resolution Imaging in Microscopy and Ophthalmology: New Frontiers in Biomedical Optics [Internet]. Cham (CH): Springer; 2019. No abstract available. Available from http://www.ncbi.nlm.nih.gov/books/NBK554051/ |
| 28663849 | Background | Liu YZ, South FA, Xu Y, Carney PS, Boppart SA. Computational optical coherence tomography [Invited]. Biomed Opt Express. 2017 Feb 16;8(3):1549-1574. doi: 10.1364/BOE.8.001549. eCollection 2017 Mar 1. |
| 19475077 | Background | Wojtkowski M, Srinivasan V, Ko T, Fujimoto J, Kowalczyk A, Duker J. Ultrahigh-resolution, high-speed, Fourier domain optical coherence tomography and methods for dispersion compensation. Opt Express. 2004 May 31;12(11):2404-22. doi: 10.1364/opex.12.002404. |
| 19259245 | Background | Chen Y, Vuong LN, Liu J, Ho J, Srinivasan VJ, Gorczynska I, Witkin AJ, Duker JS, Schuman J, Fujimoto JG. Three-dimensional ultrahigh resolution optical coherence tomography imaging of age-related macular degeneration. Opt Express. 2009 Mar 2;17(5):4046-60. doi: 10.1364/oe.17.004046. |
| 22312581 | Background | Ishida S, Nishizawa N. Quantitative comparison of contrast and imaging depth of ultrahigh-resolution optical coherence tomography images in 800-1700 nm wavelength region. Biomed Opt Express. 2012 Feb 1;3(2):282-94. doi: 10.1364/BOE.3.000282. Epub 2012 Jan 11. |
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| 30578475 | Background | Tsang SH, Sharma T. Fluorescein Angiography. Adv Exp Med Biol. 2018;1085:7-10. doi: 10.1007/978-3-319-95046-4_2. |
| 30303083 | Background | Mitchell P, Liew G, Gopinath B, Wong TY. Age-related macular degeneration. Lancet. 2018 Sep 29;392(10153):1147-1159. doi: 10.1016/S0140-6736(18)31550-2. |
| 16286620 | Background | Ferris FL, Davis MD, Clemons TE, Lee LY, Chew EY, Lindblad AS, Milton RC, Bressler SB, Klein R; Age-Related Eye Disease Study (AREDS) Research Group. A simplified severity scale for age-related macular degeneration: AREDS Report No. 18. Arch Ophthalmol. 2005 Nov;123(11):1570-4. doi: 10.1001/archopht.123.11.1570. |
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| Oct 15, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D012163 | Retinal Detachment |
| D012170 | Retinal Vein Occlusion |
| D058499 | Retinal Dystrophies |
| D015356 | Retinal Artery Occlusion |
| D010211 | Papilledema |
| D015861 | Retinal Neovascularization |
| D014605 | Uveitis |
| D003930 | Diabetic Retinopathy |
| D008269 | Macular Edema |
| D008268 | Macular Degeneration |
| D005901 | Glaucoma |
| D009901 | Optic Nerve Diseases |
| D058437 | Hypertensive Retinopathy |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D012162 | Retinal Degeneration |
| D001157 | Arterial Occlusive Diseases |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D009389 | Neovascularization, Pathologic |
| D008679 | Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014603 | Uveal Diseases |
| D003925 | Diabetic Angiopathies |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D009798 | Ocular Hypertension |
| D006973 | Hypertension |
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