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Status unknownNCT05819307STARFLIUpdated Apr 19, 2023

Structural Imaging Assisted Retinal Fluorescence Lifetime Imager (STARFLI)

An observational study in Retinal Disease, sponsored by Insel Gruppe AG, University Hospital Bern. Status unknown at 1 site in Switzerland. Open to participants aged 18 Years to 120 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-19.

Sponsored by Insel Gruppe AG, University Hospital Bern · Observational

The sponsor has not verified this record recently (last verified Mar 2023), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
70
Ages
18 Years to 120 Years
Sex
All
01

Study summary

To investigate the feasibility of a combined OCT/FLIM device

Read the detailed description

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

02

Conditions studied

  • Retinal Disease

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03

In context

Retinal Diseases

815 studies on the registry are indexed under Retinal Diseases; 105 are open to participants now.

This study's planned enrollment of 70 is below the median of 180 across 282 observational studies indexed under Retinal Diseases.

Browse Retinal Diseases studies →

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.

04

Who can participate

Ages eligible
18 Years to 120 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Retina healthy subjects

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

Exclusion Criteria:

  • Patients not willing or able to sign informed consent
  • Patients younger than 18 years
  • Patients with epilepsy
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
70 participants (estimated)
Patient registry
No

Interventions

  • DeviceOCT/FLIM

    OCT/FLIM imaging of the retina

06

What researchers measure

Primary outcomes

  1. Feasibility of device

    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.

    Time frame: 1 year

Secondary outcomes

  1. To provide two key technology aspects of the project:

    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.

    Time frame: 1 year

07

Study locations

1 site
  • Department of Ophthalmology, Bern University Hospital, Bern, 3010 Bern, Switzerland
    Bern, 3010, Switzerland
    • Martin S Zinkernagel, Prof.Dr.Dr. · Contact · martin.zinkernagel@insel.ch · +41316328503
    • Pia Steinger · Contact · pia.steinger@insel.ch · +41316328546
    • Martin Zinkernagel, Prof.Dr.Dr. · Principal investigator
    • Florian Heussen, Dr.med. · Sub investigator
    • Chantal Dysli, Dr.Dr.med. · Sub investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 19, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05819307
Lead sponsor
Insel Gruppe AG, University Hospital Bern
Collaborators
Haag-Streit AG, University of Bern
Responsible party
Sponsor
First posted
Apr 19, 2023
Start date
May 1, 2023 (estimated)
Primary completion
Dec 31, 2023 (estimated)
Completion
May 1, 2024 (estimated)
Last update
Apr 19, 2023

Study contacts

Pia Steinger
Contact
pia.steinger@insel.ch
+41316328546
Martin S. Zinkenagel, Prof.Dr.Dr.
study chair · Clinic director

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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