Structural Imaging Assisted Retinal Fluorescence Lifetime Imager (STARFLI)

Retinal Disease Clinical Trial

— STARFLI  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05819307
• Other study ID #: STARFLI
• Status: Not yet recruiting
• Start date: May 1, 2023
• Est. completion date: May 1, 2024

Study information

• Verified date: March 2023
• Source: University Hospital Inselspital, Berne
• Contact: Pia Steinger
• Phone: +41316328546
• Email: pia.steinger[@]insel.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To investigate the feasibility of a combined OCT/FLIM device

Description:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: May 1, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Retinal Disease
• Retinal Diseases

Intervention

Device:
• OCT/FLIM
OCT/FLIM imaging of the retina

Locations

Country	Name	City	State
Switzerland	Department of Ophthalmology, Bern University Hospital, Bern, 3010 Bern, Switzerland	Bern

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne	Haag-Streit AG, University of Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year
Secondary	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.	1 year