Back to resultsRPE Characterisation With Transscleral Optical Phase Imaging in Retinal Disorders (CEL01LUKS)
Primary Purpose
Retinal Disease, Eye Disease
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Clinical Trial
Sponsored by
About this trial
This is an interventional diagnostic trial for Retinal Disease
Eligibility Criteria
Inclusion Criteria:
- Informed Consent as documented by signature (Appendix Informed Consent Form)
- Patients with a medical retinal disease involving the retinal pigment epithelium (age related macular degeneration, diabetic retinopathy, retinal vascular occlusive disease, central serous chorioretinopathy, tapetoretinal degeneration)
- Participants with healthy eyes for the control group
Exclusion Criteria:
- Inability to follow the procedures of the study due to language problems, psychological disorders, dementia etc. of the participant
- Aged < 18 years.
- Pregnancy
- Epilepsy
Sites / Locations
- Kantonsspital Luzern
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Control
Patient
Arm Description
Device: Cellularis version 2.0 imaging Image acquisition of retinal pigment epithelium (RPE) cells of central retina with consecutive qualitative and quantitative description of these retinal cell layers.
Device: Cellularis version 2.0 imaging Image acquisition of retinal pigment epithelium (RPE) cells of central retina with consecutive qualitative and quantitative description of these retinal cell layers.
Outcomes
Primary Outcome Measures
RPE morphology
RPE cell density (number of cells per mm^2)
Secondary Outcome Measures
averaged RPE cell area [um2] Averaged number of neighbors of RPE cells [unitless] Averaged RPE spacing [um] Averaged RPE pigmentation parameter [unitless]
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04912622
Brief Title
RPE Characterisation With Transscleral Optical Phase Imaging in Retinal Disorders
Acronym
CEL01LUKS
Official Title
Cross Sectional Study: in Vivo Morphometric Characterisation of Human Retinal Pigment Epithelium With Transscleral Optical Phase Imaging in Photoreceptor/ Retinal Pigment Epithelium/ Bruch's Membrane/ Choriocapillaris Complex Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
May 19, 2021 (Actual)
Primary Completion Date
October 31, 2022 (Actual)
Study Completion Date
October 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Luzerner Kantonsspital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Accumulating evidence suggest that the functional unit of photoreceptor/ retinal pigment epithelium (RPE)/Bruch's membrane/choriocapillaris plays a key role in pathophysiologic processes of a wide range of medical retinal disorders of the eye. Little is known about in vivo morphometric characteristics of human RPE cells as in vivo observation of these cells was so far technically challenging and hence nearly impossible to implement in a clinical setting. Transscleral optical phase imaging is a novel in-vivo microscopy technique allowing human RPE imaging on a cellular level with the potential of clinical application in a multimodal retinal imaging approach for diagnostic purpose in medical retina patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Disease, Eye Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Control group: 110 individuals with healthy retina Patient group: 95 individuals with diseased retina Exclusion: age < 18y, pregnancy, epilepsy, no informed consent
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
210 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Experimental
Arm Description
Device: Cellularis version 2.0 imaging Image acquisition of retinal pigment epithelium (RPE) cells of central retina with consecutive qualitative and quantitative description of these retinal cell layers.
Arm Title
Patient
Arm Type
Experimental
Arm Description
Device: Cellularis version 2.0 imaging Image acquisition of retinal pigment epithelium (RPE) cells of central retina with consecutive qualitative and quantitative description of these retinal cell layers.
Intervention Type
Diagnostic Test
Intervention Name(s)
Clinical Trial
Intervention Description
Retinal image acquisition with Cellularis version 2.0
Primary Outcome Measure Information:
Title
RPE morphology
Description
RPE cell density (number of cells per mm^2)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
averaged RPE cell area [um2] Averaged number of neighbors of RPE cells [unitless] Averaged RPE spacing [um] Averaged RPE pigmentation parameter [unitless]
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Informed Consent as documented by signature (Appendix Informed Consent Form)
Patients with a medical retinal disease involving the retinal pigment epithelium (age related macular degeneration, diabetic retinopathy, retinal vascular occlusive disease, central serous chorioretinopathy, tapetoretinal degeneration)
Participants with healthy eyes for the control group
Exclusion Criteria:
Inability to follow the procedures of the study due to language problems, psychological disorders, dementia etc. of the participant
Aged < 18 years.
Pregnancy
Epilepsy
Facility Information:
Facility Name
Kantonsspital Luzern
City
Lucerne
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
RPE Characterisation With Transscleral Optical Phase Imaging in Retinal Disorders
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