FLIO Group: Measurement of Retinal Auto Fluorescence With a Fluorescence Lifetime Imaging Ophthalmoscope

Sponsor
University Hospital Inselspital, Berne (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT01981148
Collaborator
(none)
600
1
146.9
4.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Fluorescence lifetime ophthalmoscope

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
600 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Measurement of Retinal Auto Fluorescence With a Fluorescence Lifetime Imaging Ophthalmoscope
Study Start Date :
Feb 1, 2013
Anticipated Primary Completion Date :
May 1, 2025
Anticipated Study Completion Date :
May 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Healthy patients

Healthy patients

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

Patients with various retinal diseases

Various retinal diseases (vascular, hereditary, degenerative)

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

Outcome Measures

Primary Outcome Measures

  1. Fluorescence lifetime measured by a fluorescence lifetime imaging ophthalmoscope [at baseline]

    Measured by fluorescence lifetime variable (TAU). Measured once; in some patients, up to 4 measurements within 2 years will be done

Secondary Outcome Measures

  1. Repeatability of FLIO [at baseline]

    Two independent measurements

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Ophthalmology, Bern University Hospital, Bern, 3010 Bern, Switzerland Bern 3010 Switzerland 3010

Sponsors and Collaborators

  • University Hospital Inselspital, Berne

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT01981148
Other Study ID Numbers:
  • FLIO
First Posted:
Nov 11, 2013
Last Update Posted:
Oct 11, 2021
Last Verified:
Oct 1, 2021

Study Results

No Results Posted as of Oct 11, 2021