NCT05819307

Brief Summary

To investigate the feasibility of a combined OCT/FLIM device

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 19, 2023

Completed
12 days until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

April 19, 2023

Status Verified

March 1, 2023

Enrollment Period

8 months

First QC Date

March 1, 2023

Last Update Submit

April 14, 2023

Conditions

Retinal Disease

Outcome Measures

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.

    1 year

Secondary Outcomes (1)

  • To provide two key technology aspects of the project:

    1 year

Interventions

OCT/FLIMDEVICE

OCT/FLIM imaging of the retina

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Retina healthy subjects

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology, Bern University Hospital, Bern, 3010 Bern, Switzerland

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Retinal Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

  • Martin S. Zinkenagel, Prof.Dr.Dr.

    Clinic director

    STUDY CHAIR

Central Study Contacts

Pia Steinger

CONTACT

+41316328546pia.steinger@insel.ch

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2023

First Posted

April 19, 2023

Study Start

May 1, 2023

Primary Completion

December 31, 2023

Study Completion

May 1, 2024

Last Updated

April 19, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)