Study Results
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Basic Information
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UNKNOWN
550 participants
OBSERVATIONAL
2021-11-30
2023-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Diabetic Retinopathy
Patients with various degree of diabetic retinopathy
High-resolution optical coherence tomography (High-Res-OCT)
Imaging with high-resolution optical coherence tomography
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)
High-resolution optical coherence tomography (High-Res-OCT)
Imaging with high-resolution optical coherence tomography
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)
High-resolution optical coherence tomography (High-Res-OCT)
Imaging with high-resolution optical coherence tomography
Standard spectral domain OCT (SD-OCT)
Imaging with standard spectral domain OCT
Optic nerve neuropathy
Patients with history of various optic nerve neuropathies
High-resolution optical coherence tomography (High-Res-OCT)
Imaging with high-resolution optical coherence tomography
Standard spectral domain OCT (SD-OCT)
Imaging with standard spectral domain OCT
Hereditary retinal diseases
Patients with history of various retinal dystrophies
High-resolution optical coherence tomography (High-Res-OCT)
Imaging with high-resolution optical coherence tomography
Standard spectral domain OCT (SD-OCT)
Imaging with standard spectral domain OCT
Retinal detachment
Patients history of retinal detachment
High-resolution optical coherence tomography (High-Res-OCT)
Imaging with high-resolution optical coherence tomography
Standard spectral domain OCT (SD-OCT)
Imaging with standard spectral domain OCT
Age related macular degeneration
Patients with history of age related macular degeneration
High-resolution optical coherence tomography (High-Res-OCT)
Imaging with high-resolution optical coherence tomography
Standard spectral domain OCT (SD-OCT)
Imaging with standard spectral domain OCT
Retinal changes from arterial hypertension
Patients with history of arterial hypertension
High-resolution optical coherence tomography (High-Res-OCT)
Imaging with high-resolution optical coherence tomography
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
High-resolution optical coherence tomography (High-Res-OCT)
Imaging with high-resolution optical coherence tomography
Standard spectral domain OCT (SD-OCT)
Imaging with standard spectral domain OCT
Healthy
Healthy age matched control subjects
High-resolution optical coherence tomography (High-Res-OCT)
Imaging with high-resolution optical coherence tomography
Standard spectral domain OCT (SD-OCT)
Imaging with standard spectral domain OCT
Interventions
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High-resolution optical coherence tomography (High-Res-OCT)
Imaging with high-resolution optical coherence tomography
Standard spectral domain OCT (SD-OCT)
Imaging with standard spectral domain OCT
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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Insel Gruppe AG, University Hospital Bern
OTHER
Responsible Party
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Principal Investigators
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Oussama Habra, MD
Role: STUDY_CHAIR
Department of Ophthalmology, University hospital Bern
Locations
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Department of Ophthalmology, Bern University Hospital, Bern, 3010 Bern, Switzerland
Bern, Canton of Bern, Switzerland
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
Viechtbauer W, Smits L, Kotz D, Bude L, Spigt M, Serroyen J, Crutzen R. A simple formula for the calculation of sample size in pilot studies. J Clin Epidemiol. 2015 Nov;68(11):1375-9. doi: 10.1016/j.jclinepi.2015.04.014. Epub 2015 Jun 6.
de Boer JF, Cense B, Park BH, Pierce MC, Tearney GJ, Bouma BE. Improved signal-to-noise ratio in spectral-domain compared with time-domain optical coherence tomography. Opt Lett. 2003 Nov 1;28(21):2067-9. doi: 10.1364/ol.28.002067.
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/
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.
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.
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.
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.
An L, Li P, Shen TT, Wang R. High speed spectral domain optical coherence tomography for retinal imaging at 500,000 A-lines per second. Biomed Opt Express. 2011 Oct 1;2(10):2770-83. doi: 10.1364/BOE.2.002770. Epub 2011 Sep 12.
Tsang SH, Sharma T. Fluorescein Angiography. Adv Exp Med Biol. 2018;1085:7-10. doi: 10.1007/978-3-319-95046-4_2.
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.
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.
Wolf S, Wolf-Schnurrbusch U. Spectral-domain optical coherence tomography use in macular diseases: a review. Ophthalmologica. 2010;224(6):333-40. doi: 10.1159/000313814. Epub 2010 May 4.
Saito T, Rehmsmeier M. The precision-recall plot is more informative than the ROC plot when evaluating binary classifiers on imbalanced datasets. PLoS One. 2015 Mar 4;10(3):e0118432. doi: 10.1371/journal.pone.0118432. eCollection 2015.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2021-D0038
Identifier Type: REGISTRY
Identifier Source: secondary_id
High Res OCT
Identifier Type: -
Identifier Source: org_study_id
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