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CompletedNCT01981148FLIO-GroupUpdated Jun 11, 2026

Measurement of Retinal Auto Fluorescence With a Fluorescence Lifetime Imaging Ophthalmoscope

An observational study in Autofluorescence Imaging and Neuroimaging, sponsored by Insel Gruppe AG, University Hospital Bern. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-11.

Sponsored by Insel Gruppe AG, University Hospital Bern · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
892
Ages
18 Years and older
Sex
All
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Study 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.

Read the detailed 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.

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Conditions studied

  • Autofluorescence Imaging
  • Neuroimaging
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In context

Lead sponsor

Insel Gruppe AG, University Hospital Bern is the lead sponsor of 724 studies on the registry; 177 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

The study population will consist of patients and healthy subjects attending the department of ophthalmology at the University of Bern

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

Exclusion Criteria

  • Opacities of ocular media excluding detailed observation of the retina
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
892 participants (actual)

Groups and cohorts

  • Healthy patients

    Healthy patients

    Device: Fluorescence lifetime ophthalmoscope

  • Patients with various retinal diseases

    Various retinal diseases (vascular, hereditary, degenerative)

    Device: Fluorescence lifetime ophthalmoscope

Interventions

  • DeviceFluorescence lifetime ophthalmoscope

    All patients and healthy subjects will be imaged with the fluorescence lifetime ophthalmoscope

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What researchers measure

Primary outcomes

  1. 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

    Time frame: at baseline

Secondary outcomes

  1. Repeatability of FLIO

    Two independent measurements

    Time frame: at baseline

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Study locations

1 site
  • Department of Ophthalmology, Bern University Hospital, Bern, 3010 Bern, Switzerland
    Bern, 3010, Switzerland
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References and documents

Publications

  • 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. PubMed 23530995 ↗
  • 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 8;53(7):3376-86. doi: 10.1167/iovs.11-8970. PubMed 22511622 ↗
  • 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. PubMed 20552361 ↗
  • 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 ophthalmoscope in healthy subjects. Invest Ophthalmol Vis Sci. 2014 Apr 3;55(4):2106-13. doi: 10.1167/iovs.13-13627. PubMed 24569585 ↗
  • Dysli C, Dysli M, Wolf S, Zinkernagel M. Fluorescence lifetime distribution in phakic and pseudophakic healthy eyes. PLoS One. 2023 Jan 6;18(1):e0279158. doi: 10.1371/journal.pone.0279158. eCollection 2023. PubMed 36608033 ↗
  • Lincke JB, Dysli C, Jaggi D, Solberg Y, Wolf S, Zinkernagel MS. LONGITUDINAL FOVEAL FLUORESCENCE LIFETIME CHARACTERISTICS IN GEOGRAPHIC ATROPHY USING FLUORESCENCE LIFETIME IMAGING OPHTHALMOSCOPY. Retina. 2021 Nov 1;41(11):2391-2398. doi: 10.1097/IAE.0000000000003222. PubMed 34282069 ↗
  • Dysli C, Dysli M, Lincke J, Jaggi D, Wolf S, Zinkernagel MS. IMAGING ARTIFACTS IN FLUORESCENCE LIFETIME IMAGING OPHTHALMOSCOPY. Retina. 2021 Nov 1;41(11):2378-2390. doi: 10.1097/IAE.0000000000003235. PubMed 34111887 ↗
  • Dysli C, Wolf S, Hatz K, Zinkernagel MS. Fluorescence Lifetime Imaging in Stargardt Disease: Potential Marker for Disease Progression. Invest Ophthalmol Vis Sci. 2016 Mar;57(3):832-41. doi: 10.1167/iovs.15-18033. PubMed 26934141 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01981148
Lead sponsor
Insel Gruppe AG, University Hospital Bern
Responsible party
Sponsor
First posted
Nov 11, 2013
Start date
Feb 2013
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025
Last update
Jun 11, 2026

Study contacts

Martin Zinkernagel, Prof.Dr.Dr.
study chair · Inselspital, University Clinic Ophthalmology

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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