Measurement of Retinal Auto Fluorescence With a Fluorescence Lifetime Imaging Ophthalmoscope

NCT ID: NCT01981148

Last Updated: 2022-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-02-28

Study Completion Date

2025-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Autofluorescence Imaging Neuroimaging

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy patients

Healthy patients

Fluorescence lifetime ophthalmoscope

Intervention Type DEVICE

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

Patients with various retinal diseases

Various retinal diseases (vascular, hereditary, degenerative)

Fluorescence lifetime ophthalmoscope

Intervention Type DEVICE

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

Interventions

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Fluorescence lifetime ophthalmoscope

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Martin Zinkernagel, Prof.Dr.Dr.

Role: STUDY_CHAIR

Inselspital, University Clinic Ophthalmology

Locations

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Department of Ophthalmology, Bern University Hospital, Bern, 3010 Bern, Switzerland

Bern, , Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type RESULT
PMID: 23530995 (View on PubMed)

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.

Reference Type RESULT
PMID: 22511622 (View on PubMed)

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.

Reference Type RESULT
PMID: 20552361 (View on PubMed)

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.

Reference Type RESULT
PMID: 24569585 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36608033 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34282069 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34111887 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26934141 (View on PubMed)

Other Identifiers

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FLIO

Identifier Type: -

Identifier Source: org_study_id

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