High Resolution Optical Coherence Tomography

NCT05130385 | Unknown

• 2 other identifiers: High Res OCT2021-D0038
• Study Type: observational
• Target: 550
• Locations: 1 country
• Sites: 1

Brief Summary

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

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

Outcome Measures

Primary Outcomes (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)

  2 years

Secondary Outcomes (11)

• Evaluation of the sensitivity and specificity of High-Res-OCT for atrophy area

  2 years

• Evaluation of the sensitivity and specificity of High-Res-OCT for epiretinal membrane

  2 years

• Evaluation of the sensitivity and specificity of High-Res-OCT for drusen

  2 years

• Evaluation of the sensitivity and specificity of High-Res-OCT for ischemia

  2 years

• Evaluation of the sensitivity and specificity of High-Res-OCT for neovascularisation

  2 years

Other Outcomes (1)

• Correlation of pathological changes with fundus color photographs

  2 years

Study Arms (10)

Diabetic Retinopathy

Patients with various degree of diabetic retinopathy

Device: High-resolution optical coherence tomography (High-Res-OCT); Device: Standard spectral domain OCT (SD-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); Device: Standard spectral domain OCT (SD-OCT)

Glaucoma

Patients with history of glaucoma (open-angle glaucoma, chronic angle closure glaucoma)

Device: High-resolution optical coherence tomography (High-Res-OCT); Device: Standard spectral domain OCT (SD-OCT)

Optic nerve neuropathy

Patients with history of various optic nerve neuropathies

Device: High-resolution optical coherence tomography (High-Res-OCT); Device: Standard spectral domain OCT (SD-OCT)

Hereditary retinal diseases

Patients with history of various retinal dystrophies

Device: High-resolution optical coherence tomography (High-Res-OCT); Device: Standard spectral domain OCT (SD-OCT)

Retinal detachment

Patients history of retinal detachment

Device: High-resolution optical coherence tomography (High-Res-OCT); Device: Standard spectral domain OCT (SD-OCT)

Age related macular degeneration

Patients with history of age related macular degeneration

Device: High-resolution optical coherence tomography (High-Res-OCT); Device: Standard spectral domain OCT (SD-OCT)

Retinal changes from arterial hypertension

Patients with history of arterial hypertension

Device: High-resolution optical coherence tomography (High-Res-OCT); Device: Standard spectral domain OCT (SD-OCT)

Uveitis

Patients with history of uveitis intermedia and/or posterior and/or pan-uveitis

Device: High-resolution optical coherence tomography (High-Res-OCT); Device: Standard spectral domain OCT (SD-OCT)

Healthy

Healthy age matched control subjects

Device: High-resolution optical coherence tomography (High-Res-OCT); Device: Standard spectral domain OCT (SD-OCT)

Interventions

High-resolution optical coherence tomography (High-Res-OCT) DEVICE

Imaging with high-resolution optical coherence tomography

Age related macular degeneration; Artery and vein occlusion; Diabetic Retinopathy; Glaucoma; Healthy; Hereditary retinal diseases; Optic nerve neuropathy; Retinal changes from arterial hypertension; Retinal detachment; Uveitis

Standard spectral domain OCT (SD-OCT) DEVICE

Imaging with standard spectral domain OCT

Age related macular degeneration; Artery and vein occlusion; Diabetic Retinopathy; Glaucoma; Healthy; Hereditary retinal diseases; Optic nerve neuropathy; Retinal changes from arterial hypertension; Retinal detachment; Uveitis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

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

Bern, Canton of Bern, 3010, Switzerland

RECRUITING

Related Publications (16)

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  PMID: 14587817 BACKGROUND

• 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/

  PMID: 32091677 BACKGROUND

• 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.

  PMID: 28663849 BACKGROUND

• 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.

  PMID: 19475077 BACKGROUND

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  PMID: 19259245 BACKGROUND

• 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.

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• 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.

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

  PMID: 30578475 BACKGROUND

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• 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.

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MeSH Terms

Conditions

Retinal Diseases; Retinal Detachment; Retinal Vein Occlusion; Retinal Dystrophies; Retinal Artery Occlusion; Papilledema; Retinal Neovascularization; Uveitis; Diabetic Retinopathy; Macular Edema; Macular Degeneration; Glaucoma; Optic Nerve Diseases; Hypertensive Retinopathy

Condition Hierarchy (Ancestors)

Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Retinal Degeneration; Arterial Occlusive Diseases; Cranial Nerve Diseases; Nervous System Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Uveal Diseases; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Ocular Hypertension; Hypertension

Study Officials

• Oussama Habra, MD

  Department of Ophthalmology, University hospital Bern

  STUDY CHAIR

Central Study Contacts

Martin S Zinkernagel, MD, PhD

CONTACT

+41316329565; martin.zinkernagel@insel.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2021
• First Posted: November 23, 2021
• Study Start: November 30, 2021
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: November 29, 2022

Record last verified: 2022-11

Locations

CH (1)