Measurement of Retinal Auto Fluorescence With a Fluorescence Lifetime Imaging Ophthalmoscope

Neuroimaging Clinical Trial

— FLIO-Group  

Official title:

Measurement of Retinal Auto Fluorescence With a Fluorescence Lifetime Imaging Ophthalmoscope

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01981148
• Other study ID #: FLIO
• Status: Enrolling by invitation
• Start date: February 2013
• Est. completion date: May 2025

Study information

• Verified date: November 2022
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Fluorescent lifetime microscopy has emerged as a useful tool to study fluorescent lifetimes in vitro. Fluorescence lifetime represents the average amount of time a fluorophore remains in the excited state following excitation and depends on the fluorophores molecular environment. Fluorescence lifetime ophthalmoscopy (FLIO) is a technique which can quantify fluorescence lifetimes in the human retina in vivo. The purpose of this study is to investigate fluorescence lifetime characteristics in the human retina by using a FLIO. The investigators hypothesize that FLIO will allow to identify areas of retinal metabolic stress such as ischemia by detecting changes in fluorescence lifetimes.

Description:

Background

Ophthalmic imaging has made considerable progress in the last years. Especially the introduction of optical coherence tomography and the scanning laser ophthalmoscope has helped to understand the structural changes underlying various retinal diseases. However, the appearance of structural changes during retinal disease often represents irreversible functional loss with only limited treatment options. In order to prevent loss of vision, retinal diseases should ideally be diagnosed before structural changes occur. This can be achieved by imaging metabolic changes of the retina as most retinal diseases such as age related macular degeneration or diabetic retinopathy are associated with distinct metabolic changes, mainly related to oxidative stress.

Recently, a novel device for imaging fluorescent lifetimes of the retina in vivo, the fluorescent lifetime ophthalmoscope (FLIO), has been developed. This device is able to measure fluorescence lifetimes in the retina on a macroscopic level and may be able to shed new light on metabolic diseases of the retina.

Objective

To define fluorescence lifetime characteristics in healthy patients and patients with various retinal diseases.

Methods

The investigators will use a novel device, the fluorescence lifetime ophthalmoscope (FLIO) to investigate fluorescence lifetimes in the human retina.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 600
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subject must be willing to give written informed consent

• Healthy volunteers 18 years of age or greater

• Patients 18 years of age or greater

• No significant media opacities

Exclusion Criteria

• Opacities of ocular media excluding detailed observation of the retina

Related Conditions & MeSH terms

• Autofluorescence Imaging
• Neuroimaging

Intervention

Device:
• Fluorescence lifetime ophthalmoscope
All patients and healthy subjects will be imaged with the fluorescence lifetime ophthalmoscope

Locations

Country	Name	City	State
Switzerland	Department of Ophthalmology, Bern University Hospital, Bern, 3010 Bern, Switzerland	Bern 3010

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

References & Publications (4)

Dysli C, Quellec G, Abegg M, Menke MN, Wolf-Schnurrbusch U, Kowal J, Blatz J, La Schiazza O, Leichtle AB, Wolf S, Zinkernagel MS. Quantitative analysis of fluorescence lifetime measurements of the macula using the fluorescence lifetime imaging ophthalmosc — View Citation

Klemm M, Dietzel A, Haueisen J, Nagel E, Hammer M, Schweitzer D. Repeatability of autofluorescence lifetime imaging at the human fundus in healthy volunteers. Curr Eye Res. 2013 Jul;38(7):793-801. doi: 10.3109/02713683.2013.779723. Epub 2013 Mar 26. — View Citation

Schweitzer D, Gaillard ER, Dillon J, Mullins RF, Russell S, Hoffmann B, Peters S, Hammer M, Biskup C. Time-resolved autofluorescence imaging of human donor retina tissue from donors with significant extramacular drusen. Invest Ophthalmol Vis Sci. 2012 Jun — View Citation

Schweitzer D, Quick S, Klemm M, Hammer M, Jentsch S, Dawczynski J. [Time-resolved autofluorescence in retinal vascular occlusions]. Ophthalmologe. 2010 Dec;107(12):1145-52. doi: 10.1007/s00347-010-2195-7. German. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fluorescence lifetime measured by a fluorescence lifetime imaging ophthalmoscope	Measured by fluorescence lifetime variable (TAU). Measured once; in some patients, up to 4 measurements within 2 years will be done	at baseline
Secondary	Repeatability of FLIO	Two independent measurements	at baseline