Retinal DiseaseNCT03592017
Performance of Long-wavelength Autofluorescence Imaging
A study testing Long-wavelength autofluorescence imaging in people with Retinal Disease and Retinal Degeneration, run by Oxford University Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Retinal Disease, Retinal Degeneration, Retinal Dystrophies
- What is being tested?
- Long-wavelength autofluorescence imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 262 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2018to 9 Apr 2024
- Phase
- Interventional
- 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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Performance of Optimized Long-wavelength Fundus Autofluorescence Imaging in Patients With Retinal Diseases
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.
Read the 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.
- Conditions
- Retinal Disease, Retinal Degeneration, Retinal Dystrophies
- Being tested
- Long-wavelength autofluorescence imaging
- Medical subject headings
- Retinal Diseases, Retinal Degeneration, Retinal Dystrophies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long-wavelength autofluorescence imagingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with various retinal diseases | Experimental | 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 Receives: Device: Long-wavelength autofluorescence imaging |
| Healthy participants | Experimental | 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. Receives: Device: Long-wavelength autofluorescence imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
Secondary outcomes (2)
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.
Measured: 1 day
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
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start1 Oct 2018
- Primary completion9 Apr 2024
- Study completion9 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxford University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Charbel Issa, DPhil, MD, Principal investigator, Oxford Eye Hospital, The West Wing John Radcliffe Hospital Oxford, OX3 9DU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03592017
- Sponsor's protocol ID
- 13703
- Status last verified
- Aug 2024
- First submitted
- 9 Jul 2018
- Last updated
- 21 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of Optimized Long-wavelength Fundus Autofluorescence Imaging in Patients With Retinal Diseases
- ClinicalTrials.gov ID
- NCT03592017
- Acronym / sponsor ID
- 13703
- Conditions
- Retinal Disease, Retinal Degeneration, Retinal Dystrophies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- Oxford University Hospitals NHS TrustUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 9 Apr 2024 (actual)
- Study completion
- 9 Apr 2024 (actual)
- First posted
- 19 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with various retinal diseases | Experimental | Device: Long-wavelength autofluorescence imagingPatients 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 | Experimental | Device: Long-wavelength autofluorescence imagingHealthy 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Long-wavelength autofluorescence imagingLong-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. | Device | Healthy participants, Patients with various retinal diseases |
Primary outcome
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
2 secondary outcomes
Optimization of the signal of long-wavelength autofluorescence imaging using different laser and filter settings
Time frame: 1 day
Quantification of the optimized signal of long-wavelength autofluorescence imaging in healthy controls and participants with various retinal diseases
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Charbel Issa, DPhil, MD principal investigator
Oxford Eye Hospital, The West Wing John Radcliffe Hospital Oxford, OX3 9DU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Long-wavelength autofluorescence imaging in people with Retinal Disease and Retinal Degeneration, run by Oxford University Hospitals NHS Trust at 1 site in United Kingdom.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 21 Aug 2024. 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of long-wavelength autofluorescence imaging (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Aug 2024.