Structural Imaging Assisted Retinal Fluorescence Lifetime Imager (STARFLI) (STARFLI)

April 14, 2023 updated by: University Hospital Inselspital, Berne

Structural Imaging Assisted Retinal Fluorescence Lifetime Imager (STARFLI) Using a High-speed Fluorescence Lifetime Measurement Scheme

To investigate the feasibility of a combined OCT/FLIM device

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

To investigate the feasibility of a combined Optical coherence tomography/ Fluorescence Lifetime Measurement (OCT/FLIM) device.

Study Type

Observational

Enrollment (Anticipated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Switzerland
      • Bern, Switzerland, 3010
        • Department of Ophthalmology, Bern University Hospital, Bern, 3010 Bern, Switzerland
        • Contact:
        • Contact:
        • Principal Investigator:
          • Martin Zinkernagel, Prof.Dr.Dr.
        • Sub-Investigator:
          • Florian Heussen, Dr.med.
        • Sub-Investigator:
          • Chantal Dysli, Dr.Dr.med.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Retina healthy subjects

Description

Inclusion Criteria:

  • Subject must be willing to give written informed consent
  • Age: Patients and Probands 18 years or greater
  • Both eyes will be assessed in the study

Exclusion Criteria:

  • Patients not willing or able to sign informed consent
  • Patients younger than 18 years
  • Patients with epilepsy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of device
Time Frame: 1 year
We will organize and perform an observational study with the prototype OCT+FLIM device and contribute the acquired OCT/FLIM datasets from eyes of different age and status of the crystalline lens.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To provide two key technology aspects of the project:
Time Frame: 1 year

A. The first will be to bring forward a novel registration strategy for calibrated OCT and FLIM modalities, so that these can be used in conjunction.

B. The second will be to develop an image calibration and normalization method using the measured lens fluorescence lifetime and possibly also structural (OCT) information on lens and retina, so that data acquired by the device can be used across different patients in a consistent way.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Inselspital, Berne

Collaborators

University of Bern
Haag-Streit AG

Investigators

  • Study Chair: Martin S. Zinkenagel, Prof.Dr.Dr., Clinic Director

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2023

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

May 1, 2024

Study Registration Dates

First Submitted

March 1, 2023

First Submitted That Met QC Criteria

April 14, 2023

First Posted (Actual)

April 19, 2023

Study Record Updates

Last Update Posted (Actual)

April 19, 2023

Last Update Submitted That Met QC Criteria

April 14, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STARFLI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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