Clinical trial NCT05130385: High Resolution Optical Coherence Tomography
Official title: Investigation of Retinal Pathology in Eye Diseases Using High Resolution Optical Coherence Tomography (High-Res-OCT)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
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
Keywords: Optical Coherence Tomography
Diagnostic Techniques, Ophthalmological
High resolution optical coherence tomography
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2021-11-23
Enrollment: 550
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

Brief 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)

Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of the sensitivity and specificity of High-Res-OCT for retinal fluid
timeFrame: 2 years
Secondary outcomes:
measure: Evaluation of the sensitivity and specificity of High-Res-OCT for atrophy area
timeFrame: 2 years
measure: Evaluation of the sensitivity and specificity of High-Res-OCT for epiretinal membrane
timeFrame: 2 years
measure: Evaluation of the sensitivity and specificity of High-Res-OCT for drusen
timeFrame: 2 years
measure: Evaluation of the sensitivity and specificity of High-Res-OCT for ischemia
timeFrame: 2 years
measure: Evaluation of the sensitivity and specificity of High-Res-OCT for neovascularisation
timeFrame: 2 years
measure: Evaluation of the sensitivity and specificity of High-Res-OCT for optic disc swelling
timeFrame: 2 years
measure: Evaluation of the sensitivity and specificity of High-Res-OCT for hyperreflective foci
timeFrame: 2 years
measure: Evaluation of the sensitivity and specificity of High-Res-OCT for scars
timeFrame: 2 years
measure: Evaluation of the inter-reader reproducibility
timeFrame: 2 years
measure: Subgroup analysis
timeFrame: 2 years
measure: Evaluation of the segmentation quality of the retinal layers using High-Res-OCT
timeFrame: 2 years
Other outcomes:
measure: Correlation of pathological changes with fundus color photographs
timeFrame: 2 years
Locations:
city: Bern 3010
country: Switzerland
facility: Department of Ophthalmology, Bern University Hospital, Bern, 3010 Bern, Switzerland
state: Bern
Study officials:
affiliation: Department of Ophthalmology, University hospital Bern
name: Oussama Habra, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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/
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Tsang SH, Sharma T. Fluorescein Angiography. Adv Exp Med Biol. 2018;1085:7-10. doi: 10.1007/978-3-319-95046-4_2.
citation: 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.
citation: 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.
citation: 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.
citation: 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.