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Performance of Long-wavelength Autofluorescence Imaging

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ClinicalTrials.gov Identifier: NCT03592017
Recruitment Status : Not yet recruiting
First Posted : July 19, 2018
Last Update Posted : August 22, 2018
Sponsor:
Information provided by (Responsible Party):
Peter Charbel Issa, Oxford University Hospitals NHS Trust

Brief Summary:
Fundus autofluorescence imaging has become an important diagnostic tool in ophthalmology, guiding diagnosis and assessment of progression of retinal diseases. This study investigates the performance of optimized long-wavelength autofluorescence imaging. To achieve this goal, the investigators will determine an optimal long wavelength excitation light and investigate the autofluorescence signal intensity in normals and patients with different retinal diseases. The diagnostic performance of the long-wavelength autofluorescence will be evaluated by assessing sensitivity and specificity for diagnosing a variety of degenerative retinal diseases and by comparing it to conventional autofluorescence.

Condition or disease Intervention/treatment Phase
Retinal Disease Retinal Degeneration Retinal Dystrophies Device: Long-wavelength autofluorescence imaging Not Applicable

Detailed Description:

Fundus autofluorescence (AF) imaging of the retina with confocal scanning laser ophthalmoscopy has been established as a non-invasive imaging modality for the diagnosis of retinal and macular diseases. Long-wavelength near-infrared autofluorescence (excitation: 787 nm, LW-AF) is a new, innovative alternative to the classic autofluorescence imaging using 488 nm blue excitation light. Excitation of the fluorophores at the ocular fundus using a longer wavelength has several advantages. However, with the current imaging technique the autofluorescence signal and thus image quality is considerably lower compared to conventional short-wavelength autofluorescence (SW-AF). This may be the main reason for the currently limited application and scarce scientific publications on this technique.

Therefore, the objective of this study is to assess the performance of an optimized setup of long-wavelength autofluorescence imaging in clinical routine applications. For this purpose, additional laser sources will be integrated into a scanning laser ophthalmoscope and the performance with regards to image quality will be investigated systematically using different excitation wavelengths and filter combinations in healthy controls.

In a next step, the signal intensity will be quantified using an integrated fluorescent reference. First, factors affecting measurements will be identified, followed by generation of a normative database. Subjects with various retinal diseases will then be investigated and compared to the normative database.

Finally, the diagnostic performance of long-wavelength autofluorescence imaging to detect retinal degenerative diseases will be investigated and compared to conventional imaging techniques.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Performance of Optimized Long-wavelength Fundus Autofluorescence Imaging in Patients With Retinal Diseases
Estimated Study Start Date : October 1, 2018
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2020


Arm Intervention/treatment
Experimental: Patients with various retinal diseases
Patients with various retinal diseases will be examined using long-wavelength autofluorescence imaging to assess the performance compared to conventional imaging methods and to quantify the signal compared to a normative database
Device: Long-wavelength autofluorescence imaging
Long-wavelength autofluorescence imaging will be performed with a prototype confocal scanning laser (cSLO) ophthalmoscope which will be equipped with additional laser sources and a reference for quantification of the signal. The experimental long-wavelength laser sources will be integrated into a custom-modified Spectralis HRA cSLO from Heidelberg Engineering. The additional laser sources will operate with long wavelength which are less energetic compared to the conventional short-wavelength lasers used currently for routine autofluorescence imaging. All safety standards have been considered and the light exposure for all imaging modes is well below the exposure limits for Class 1 and Class1M laser products as defined in the standard IEC 60825-1, edition 3.0, 2014-5.

Experimental: Healthy participants
Healthy participants will be examined using long-wavelength autofluorescence imaging to optimize the signal with additional laser sources and device settings and to compile a normative database for the quantification of the signal.
Device: Long-wavelength autofluorescence imaging
Long-wavelength autofluorescence imaging will be performed with a prototype confocal scanning laser (cSLO) ophthalmoscope which will be equipped with additional laser sources and a reference for quantification of the signal. The experimental long-wavelength laser sources will be integrated into a custom-modified Spectralis HRA cSLO from Heidelberg Engineering. The additional laser sources will operate with long wavelength which are less energetic compared to the conventional short-wavelength lasers used currently for routine autofluorescence imaging. All safety standards have been considered and the light exposure for all imaging modes is well below the exposure limits for Class 1 and Class1M laser products as defined in the standard IEC 60825-1, edition 3.0, 2014-5.




Primary Outcome Measures :
  1. Performance of long-wavelength autofluorescence imaging [ Time Frame: 1 day ]
    The sensitivity and specificity to detect characteristics in retinal diseases will be investigated in patients with various retinal diseases and compared to conventional imaging methods


Secondary Outcome Measures :
  1. Optimization of the signal of long-wavelength autofluorescence imaging using different laser and filter settings [ Time Frame: 1 day ]
    To optimize the signal of long-wavelength autofluorescence imaging, the fluorescence intensity of the different laser sources and filter settings will be assessed.

  2. Quantification of the optimized signal of long-wavelength autofluorescence imaging in healthy controls and participants with various retinal diseases [ Time Frame: 1 day ]
    To quantify the optimized signal of long-wavelength autofluorescence imaging the absolute fluorescence intensity compared to a fluorescent reference will be assessed in patients with various retinal diseases and compared to healthy controls



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18 years or above
  • Defined retinal disease (patients) or no known retinal disease (healthy participants)
  • Participants willing to read and understand the study information and provide informed consent
  • Participants agree to have some examinations and photographs taken from their eyes

Exclusion Criteria:

  • Significant opacities of the ocular media
  • difficulties positioning still in front of the camera
  • any ocular/ general disease known to affect recordings and/or analysis of retinal images
  • Pupil diameter <5mm

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03592017


Contacts
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Contact: Peter Charbel Issa, DPhil, MD +44 1865 234737 study-enquiry@outlook.com
Contact: Martin Gliem, MD martin.gliem@ouh.nhs.uk

Locations
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United Kingdom
Oxford Eye Hospital Not yet recruiting
Oxford, United Kingdom, OX3 9DU
Contact: Peter Charbel Issa, DPhil    +44 1865 234737    study-enquiry@outlook.com   
Contact: Martin Gliem, MD       martin.gliem@ouh.nhs.uk   
Sponsors and Collaborators
Oxford University Hospitals NHS Trust
Investigators
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Principal Investigator: Peter Charbel Issa, DPhil, MD Oxford Eye Hospital, The West Wing John Radcliffe Hospital Oxford, OX3 9DU

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Responsible Party: Peter Charbel Issa, Primary Investigator, Consultant Opthalmologist, Oxford University Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT03592017     History of Changes
Other Study ID Numbers: 13703
First Posted: July 19, 2018    Key Record Dates
Last Update Posted: August 22, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Retinal Diseases
Retinal Degeneration
Retinal Dystrophies
Eye Diseases
Eye Diseases, Hereditary