High Resolution Optical Coherence Tomography

November 28, 2022 updated by: University Hospital Inselspital, Berne

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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)

Study Type

Observational

Enrollment (Anticipated)

550

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Switzerland
    • Bern
      • Bern 3010, Bern, Switzerland, 3010
        • Recruiting
        • Department of Ophthalmology, Bern University Hospital, Bern, 3010 Bern, Switzerland
        • Contact:
        • Principal Investigator:
          • Martin S Zinkernagel, Prof.Dr.Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Diabetic Retinopathy
Patients with various degree of diabetic retinopathy
Device: High-resolution optical coherence tomography (High-Res-OCT)
Imaging with high-resolution optical coherence tomography
Device: 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)
Device: High-resolution optical coherence tomography (High-Res-OCT)
Imaging with high-resolution optical coherence tomography
Device: 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)
Device: High-resolution optical coherence tomography (High-Res-OCT)
Imaging with high-resolution optical coherence tomography
Device: Standard spectral domain OCT (SD-OCT)
Imaging with standard spectral domain OCT
Optic nerve neuropathy
Patients with history of various optic nerve neuropathies
Device: High-resolution optical coherence tomography (High-Res-OCT)
Imaging with high-resolution optical coherence tomography
Device: Standard spectral domain OCT (SD-OCT)
Imaging with standard spectral domain OCT
Hereditary retinal diseases
Patients with history of various retinal dystrophies
Device: High-resolution optical coherence tomography (High-Res-OCT)
Imaging with high-resolution optical coherence tomography
Device: Standard spectral domain OCT (SD-OCT)
Imaging with standard spectral domain OCT
Retinal detachment
Patients history of retinal detachment
Device: High-resolution optical coherence tomography (High-Res-OCT)
Imaging with high-resolution optical coherence tomography
Device: Standard spectral domain OCT (SD-OCT)
Imaging with standard spectral domain OCT
Age related macular degeneration
Patients with history of age related macular degeneration
Device: High-resolution optical coherence tomography (High-Res-OCT)
Imaging with high-resolution optical coherence tomography
Device: Standard spectral domain OCT (SD-OCT)
Imaging with standard spectral domain OCT
Retinal changes from arterial hypertension
Patients with history of arterial hypertension
Device: High-resolution optical coherence tomography (High-Res-OCT)
Imaging with high-resolution optical coherence tomography
Device: 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
Device: High-resolution optical coherence tomography (High-Res-OCT)
Imaging with high-resolution optical coherence tomography
Device: Standard spectral domain OCT (SD-OCT)
Imaging with standard spectral domain OCT
Healthy
Healthy age matched control subjects
Device: High-resolution optical coherence tomography (High-Res-OCT)
Imaging with high-resolution optical coherence tomography
Device: Standard spectral domain OCT (SD-OCT)
Imaging with standard spectral domain OCT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the sensitivity and specificity of High-Res-OCT for retinal fluid
Time Frame: 2 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the sensitivity and specificity of High-Res-OCT for atrophy area
Time Frame: 2 years
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
Evaluation of the sensitivity and specificity of High-Res-OCT for epiretinal membrane
Time Frame: 2 years
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
Time Frame: 2 years
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
Time Frame: 2 years
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
Time Frame: 2 years
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
Time Frame: 2 years
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
Time Frame: 2 years
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
Time Frame: 2 years
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
Time Frame: 2 years
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
Time Frame: 2 years
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
Time Frame: 2 years
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of pathological changes with fundus color photographs
Time Frame: 2 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Inselspital, Berne

Investigators

  • Study Chair: Oussama Habra, MD, Department of Ophthalmology, University Hospital Bern

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2021

Primary Completion (Anticipated)

November 30, 2023

Study Completion (Anticipated)

November 30, 2023

Study Registration Dates

First Submitted

October 15, 2021

First Submitted That Met QC Criteria

November 17, 2021

First Posted (Actual)

November 23, 2021

Study Record Updates

Last Update Posted (Actual)

November 29, 2022

Last Update Submitted That Met QC Criteria

November 28, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • High Res OCT
  • 2021-D0038 (Registry Identifier: Swiss National Clinical Trials Portal)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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