High Resolution Optical Coherence Tomography

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05130385
• Other study ID #: High Res OCT
• Secondary ID: 2021-D0038
• Status: Recruiting
• Start date: November 30, 2021
• Est. completion date: November 30, 2023

Study information

• Verified date: November 2022
• Source: University Hospital Inselspital, Berne
• Contact: Martin S Zinkernagel, MD, PhD
• Phone: +41316329565
• Email: martin.zinkernagel[@]insel.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 550
• Est. completion date: November 30, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Diabetic Retinopathy
• Edema
• Glaucoma
• Hypertensive Retinopathy
• Macular Degeneration
• Macular Disease
• Macular Edema
• Neovascularization, Pathologic
• Optic Nerve Diseases
• Papilledema
• Retinal Artery Occlusion
• Retinal Detachment
• Retinal Disease
• Retinal Diseases
• Retinal Dystrophies
• Retinal Dystrophy
• Retinal Edema
• Retinal Neovascularization
• Retinal Vein Occlusion
• Uveitis

Intervention

Device:
• 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

Locations

Country	Name	City	State
Switzerland	Department of Ophthalmology, Bern University Hospital, Bern, 3010 Bern, Switzerland	Bern 3010	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

References & Publications (16)

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. — View Citation

Aumann S, Donner S, Fischer J, Müller F. Optical Coherence Tomography (OCT): Principle and Technical Realization. In: Bille JF, ed. High Resolution Imaging in Microscopy and Ophthalmology: New Frontiers in Biomedical Optics. Cham: Springer International Publishing; 2019: 59-85.

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. — View 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. — View 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. — View 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. Review. — View 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. — View 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. — View 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. — View 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. Review. — View 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. Review. — View 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. — View Citation

Tsang SH, Sharma T. Fluorescein Angiography. Adv Exp Med Biol. 2018;1085:7-10. doi: 10.1007/978-3-319-95046-4_2. — View 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. — View 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. — View 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. Review. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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