Measurement of Retinal Auto Fluorescence With a Fluorescence Lifetime Imaging Ophthalmoscope

NCT01981148 | Unknown DMC

• 1 other identifier: FLIO
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Autofluorescence Imaging; Neuroimaging

Outcome Measures

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

  at baseline

Secondary Outcomes (1)

• Repeatability of FLIO

  at baseline

Study Arms (2)

Healthy patients

Healthy patients

Device: Fluorescence lifetime ophthalmoscope

Patients with various retinal diseases

Various retinal diseases (vascular, hereditary, degenerative)

Device: Fluorescence lifetime ophthalmoscope

Interventions

Fluorescence lifetime ophthalmoscope DEVICE

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

Healthy patients; Patients with various retinal diseases

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• Opacities of ocular media excluding detailed observation of the retina

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

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

Bern, 3010, Switzerland

Location

Related Publications (8)

• 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.

  PMID: 23530995 RESULT

• 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.

  PMID: 22511622 RESULT

• 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.

  PMID: 20552361 RESULT

• 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.

  PMID: 24569585 RESULT

• 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.

  PMID: 36608033 DERIVED

• 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.

  PMID: 34282069 DERIVED

• 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.

  PMID: 34111887 DERIVED

• 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.

  PMID: 26934141 DERIVED

Study Officials

• Martin Zinkernagel, Prof.Dr.Dr.

  Inselspital, University Clinic Ophthalmology

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2013
• First Posted: November 11, 2013
• Study Start: February 1, 2013
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: December 5, 2022

Record last verified: 2022-11

Locations

CH (1)