Retinal DiseaseSTARFLINCT05819307
Structural Imaging Assisted Retinal Fluorescence Lifetime Imager (STARFLI)
An observational study of Retinal Disease, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
To investigate the feasibility of a combined OCT/FLIM device Read more about this study
- Who is it for?
- Ages 18 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Retinal Disease
- What is being tested?
- OCT/FLIM
- Type of treatment
- Medical device
- How many people
- 70 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 May 2023to 1 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Retina healthy subjects
Who may be able to join
- 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
Who cannot join
- Patients not willing or able to sign informed consent
- Patients younger than 18 years
- Patients with epilepsy
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Ophthalmology, Bern University Hospital, Bern, 3010 Bern, Switzerland
Bern, 3010
Martin S Zinkernagel, Prof.Dr.Dr., +41316328503, martin.zinkernagel@insel.ch
Pia Steinger, +41316328546, pia.steinger@insel.ch
About this study
Official title: 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
Read the detailed description
To investigate the feasibility of a combined Optical coherence tomography/ Fluorescence Lifetime Measurement (OCT/FLIM) device.
- Conditions
- Retinal Disease
- Being tested
- OCT/FLIM
- Medical subject headings
- Retinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCT/FLIMDevice
OCT/FLIM imaging of the retina
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (1)
To provide two key technology aspects of the project:
- 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.
- 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start1 May 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Haag-Streit AG, University of Bern
- Responsible party
- Sponsor
- Investigators
- Martin S. Zinkenagel, Prof.Dr.Dr., Study chair, Clinic director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05819307
- Sponsor's protocol ID
- STARFLI
- Acronym
- STARFLI
- Status last verified
- Mar 2023
- First submitted
- 1 Mar 2023
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Structural Imaging Assisted Retinal Fluorescence Lifetime Imager (STARFLI) Using a High-speed Fluorescence Lifetime Measurement Scheme
- ClinicalTrials.gov ID
- NCT05819307
- Acronym / sponsor ID
- STARFLI / STARFLI
- Conditions
- Retinal Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Haag-Streit AG, University of Bern
- Study start
- 1 May 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 19 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the feasibility of a combined OCT/FLIM device
Detailed description
To investigate the feasibility of a combined Optical coherence tomography/ Fluorescence Lifetime Measurement (OCT/FLIM) device.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Retina healthy subjects
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Patients not willing or able to sign informed consent
- Patients younger than 18 years
- Patients with epilepsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OCT/FLIMOCT/FLIM imaging of the retina | Device | – |
Primary outcome
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 secondary outcome
To provide two key technology aspects of the project:
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin S. Zinkenagel, Prof.Dr.Dr. study chair
Clinic director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinal Disease, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pia Steinger (+41316328546, pia.steinger@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of device (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2023; AzTrials last refreshed its copy on 30 Oct 2026.