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Retinal DiseaseNCT05130385

High Resolution Optical Coherence Tomography

An observational study of Retinal Disease and Retinal Detachment, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
High-resolution optical coherence tomography (High-Res-OCT) and Standard spectral domain OCT (SD-OCT)
Type of treatment
Medical device
How many people
550 participants
Where
1 siteSwitzerland
Study dates
30 Nov 2021to 30 Nov 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Martin S Zinkernagel, MD, PhD contact

+41316329565

martin.zinkernagel@insel.ch

Switzerland1 site, 1 recruiting

  • Department of Ophthalmology, Bern University Hospital, Bern, 3010 Bern, Switzerland

    Bern, Canton of Bern, 3010

    Martin S Zinkernagel, MD, PhD, +41316329565, martin.zinkernagel@insel.ch

    Martin S Zinkernagel, Prof.Dr.Dr.

    Recruiting

Other trials in Switzerland

About this study

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

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

Read the 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)

Being tested
High-resolution optical coherence tomography (High-Res-OCT), Standard spectral domain OCT (SD-OCT)
Keywords
Optical Coherence Tomography, Diagnostic Techniques, Ophthalmological, High resolution optical coherence tomography
Medical subject headings
Retinal Diseases, Retinal Detachment, Retinal Vein Occlusion, Retinal Dystrophies, Retinal Artery Occlusion, Papilledema, Retinal Neovascularization, Uveitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High-resolution optical coherence tomography (High-Res-OCT)Device

    Imaging with high-resolution optical coherence tomography

  • Standard spectral domain OCT (SD-OCT)Device

    Imaging with standard spectral domain OCT

Study groups in NCT05130385
Study groupRoleWhat they receive
Diabetic RetinopathyPatients with various degree of diabetic retinopathy
Receives: Device: High-resolution optical coherence tomography (High-Res-OCT); Device: Standard spectral domain OCT (SD-OCT)
Artery and vein occlusionPatients with history of artery or vein occlusion (central or branch artery)
Receives: Device: High-resolution optical coherence tomography (High-Res-OCT); Device: Standard spectral domain OCT (SD-OCT)
GlaucomaPatients with history of glaucoma (open-angle glaucoma, chronic angle closure glaucoma)
Receives: Device: High-resolution optical coherence tomography (High-Res-OCT); Device: Standard spectral domain OCT (SD-OCT)
Optic nerve neuropathyPatients with history of various optic nerve neuropathies
Receives: Device: High-resolution optical coherence tomography (High-Res-OCT); Device: Standard spectral domain OCT (SD-OCT)
Hereditary retinal diseasesPatients with history of various retinal dystrophies
Receives: Device: High-resolution optical coherence tomography (High-Res-OCT); Device: Standard spectral domain OCT (SD-OCT)
Retinal detachmentPatients history of retinal detachment
Receives: Device: High-resolution optical coherence tomography (High-Res-OCT); Device: Standard spectral domain OCT (SD-OCT)
Age related macular degenerationPatients with history of age related macular degeneration
Receives: Device: High-resolution optical coherence tomography (High-Res-OCT); Device: Standard spectral domain OCT (SD-OCT)
Retinal changes from arterial hypertensionPatients with history of arterial hypertension
Receives: Device: High-resolution optical coherence tomography (High-Res-OCT); Device: Standard spectral domain OCT (SD-OCT)
UveitisPatients with history of uveitis intermedia and/or posterior and/or pan-uveitis
Receives: Device: High-resolution optical coherence tomography (High-Res-OCT); Device: Standard spectral domain OCT (SD-OCT)
HealthyHealthy age matched control subjects
Receives: Device: High-resolution optical coherence tomography (High-Res-OCT); Device: Standard spectral domain OCT (SD-OCT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 2 years

Secondary outcomes (11)

  1. 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)

    Measured: 2 years

  2. 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)

    Measured: 2 years

  3. 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).

    Measured: 2 years

  4. 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.

    Measured: 2 years

  5. 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.

    Measured: 2 years

  6. 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).

    Measured: 2 years

  7. 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.

    Measured: 2 years

  8. 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.

    Measured: 2 years

  9. 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).

    Measured: 2 years

  10. 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.

    Measured: 2 years

  11. 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.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Nov 2021
  2. Study start30 Nov 2021
  3. Primary completion30 Nov 2023 (estimated)
  4. Study completion30 Nov 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
550 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05130385
Sponsor's protocol ID
High Res OCT
Other IDs
2021-D0038
Status last verified
Nov 2022
First submitted
15 Oct 2021
Last updated
29 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 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.

    PubMed 30560558

  • 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.

    PubMed 7804919

  • 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.

    PubMed 26146089

  • 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.

    PubMed 14587817

  • 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/

    PubMed 32091677

  • 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.

    PubMed 28663849

  • 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.

    PubMed 19475077

  • 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.

    PubMed 19259245

  • 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.

    PubMed 22312581

  • 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.

    PubMed 22025983

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

    PubMed 30578475

  • 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.

    PubMed 30303083

  • 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.

    PubMed 16286620

  • 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.

    PubMed 20453539

Questions about this trial

What is this clinical trial studying?

An observational study of Retinal Disease and Retinal Detachment, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Martin S Zinkernagel, MD, PhD (+41316329565, martin.zinkernagel@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of the sensitivity and specificity of High-Res-OCT for retinal fluid (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05130385, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2022.

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