Structural Imaging Assisted Retinal Fluorescence Lifetime Imager (STARFLI)

Sponsor
University Hospital Inselspital, Berne (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05819307
Collaborator
Haag-Streit AG (Industry), University of Bern (Other)
70
1
12
5.8

Study Details

Study Description

Brief Summary

To investigate the feasibility of a combined OCT/FLIM device

Condition or Disease Intervention/Treatment Phase
  • Device: OCT/FLIM

Detailed Description

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

Study Design

Study Type:
Observational
Anticipated Enrollment :
70 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Structural Imaging Assisted Retinal Fluorescence Lifetime Imager (STARFLI) Using a High-speed Fluorescence Lifetime Measurement Scheme
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
May 1, 2024

Outcome Measures

Primary Outcome Measures

  1. Feasibility of device [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.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 120 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

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

Sponsors and Collaborators

  • University Hospital Inselspital, Berne
  • Haag-Streit AG
  • University of Bern

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT05819307
Other Study ID Numbers:
  • STARFLI
First Posted:
Apr 19, 2023
Last Update Posted:
Apr 19, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 19, 2023