Clinical trial NCT03592017: Performance of Long-wavelength Autofluorescence Imaging
Official title: Performance of Optimized Long-wavelength Fundus Autofluorescence Imaging in Patients With Retinal Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retinal Disease
Retinal Degeneration
Retinal Dystrophies
Lead sponsor: Oxford University Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2018-07-19
Enrollment: 262
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Performance of long-wavelength autofluorescence imaging
timeFrame: 1 day
Secondary outcomes:
measure: Optimization of the signal of long-wavelength autofluorescence imaging using different laser and filter settings
timeFrame: 1 day
measure: Quantification of the optimized signal of long-wavelength autofluorescence imaging in healthy controls and participants with various retinal diseases
timeFrame: 1 day
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Oxford Eye Hospital
Study officials:
affiliation: Oxford Eye Hospital, The West Wing John Radcliffe Hospital Oxford, OX3 9DU
name: Peter Charbel Issa, DPhil, MD
role: PRINCIPAL_INVESTIGATOR
References: