Performance of Long-wavelength Autofluorescence Imaging

NCT03592017 | Completed

• 1 other identifier: 13703
• Study Type: interventional
• Target: 262
• Locations: 1 country
• Sites: 1

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.

Conditions

Retinal Disease; Retinal Degeneration; Retinal Dystrophies

Outcome Measures

Primary Outcomes (1)

• 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

  1 day

Secondary Outcomes (2)

• Optimization of the signal of long-wavelength autofluorescence imaging using different laser and filter settings

  1 day

• Quantification of the optimized signal of long-wavelength autofluorescence imaging in healthy controls and participants with various retinal diseases

  1 day

Study Arms (2)

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

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.

Device: Long-wavelength autofluorescence imaging

Interventions

Long-wavelength autofluorescence imaging DEVICE

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.

Healthy participants; Patients with various retinal diseases

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oxford University Hospitals NHS Trust: lead

Study Sites (1)

Oxford Eye Hospital

Oxford, OX3 9DU, United Kingdom

Location

MeSH Terms

Conditions

Retinal Diseases; Retinal Degeneration; Retinal Dystrophies

Condition Hierarchy (Ancestors)

Eye Diseases; Eye Diseases, Hereditary

Study Officials

• Peter Charbel Issa, DPhil, MD

  Oxford Eye Hospital, The West Wing John Radcliffe Hospital Oxford, OX3 9DU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2018
• First Posted: July 19, 2018
• Study Start: October 1, 2018
• Primary Completion: April 9, 2024
• Study Completion: April 9, 2024
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)