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Performance of Long-wavelength Autofluorescence Imaging

Primary Purpose

Retinal Disease, Retinal Degeneration, Retinal Dystrophies

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Long-wavelength autofluorescence imaging
Sponsored by
Oxford University Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Retinal Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Oxford Eye HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Patients with various retinal diseases

Healthy participants

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Performance of long-wavelength autofluorescence imaging
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

Optimization of the signal of long-wavelength autofluorescence imaging using different laser and filter settings
To optimize the signal of long-wavelength autofluorescence imaging, the fluorescence intensity of the different laser sources and filter settings will be assessed.
Quantification of the optimized signal of long-wavelength autofluorescence imaging in healthy controls and participants with various retinal diseases
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

Full Information

First Posted
July 9, 2018
Last Updated
July 20, 2021
Sponsor
Oxford University Hospitals NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT03592017
Brief Title
Performance of Long-wavelength Autofluorescence Imaging
Official Title
Performance of Optimized Long-wavelength Fundus Autofluorescence Imaging in Patients With Retinal Diseases
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
July 30, 2022 (Anticipated)
Study Completion Date
July 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oxford University Hospitals NHS Trust

4. Oversight

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

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Disease, Retinal Degeneration, Retinal Dystrophies

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with various retinal diseases
Arm Type
Experimental
Arm Description
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
Arm Title
Healthy participants
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Long-wavelength autofluorescence imaging
Intervention Description
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 Measure Information:
Title
Performance of long-wavelength autofluorescence imaging
Description
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
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Optimization of the signal of long-wavelength autofluorescence imaging using different laser and filter settings
Description
To optimize the signal of long-wavelength autofluorescence imaging, the fluorescence intensity of the different laser sources and filter settings will be assessed.
Time Frame
1 day
Title
Quantification of the optimized signal of long-wavelength autofluorescence imaging in healthy controls and participants with various retinal diseases
Description
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
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peter Charbel Issa, DPhil, MD
Phone
+44 1865 234737
Email
study-enquiry@outlook.com
First Name & Middle Initial & Last Name or Official Title & Degree
Johannes Birtel, MD
Email
study-enquiry@outlook.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Charbel Issa, DPhil, MD
Organizational Affiliation
Oxford Eye Hospital, The West Wing John Radcliffe Hospital Oxford, OX3 9DU
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oxford Eye Hospital
City
Oxford
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Charbel Issa, DPhil
Phone
+44 1865 234737
Email
study-enquiry@outlook.com
First Name & Middle Initial & Last Name & Degree
Johannes Birtel, MD
Email
study-enquiry@outlook.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Performance of Long-wavelength Autofluorescence Imaging

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