RPE Characterisation With Transscleral Optical Phase Imaging in Retinal Disorders (CEL01LUKS)
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ClinicalTrials.gov Identifier: NCT04912622 |
Recruitment Status :
Recruiting
First Posted : June 3, 2021
Last Update Posted : June 3, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Retinal Disease Eye Disease | Diagnostic Test: Clinical Trial | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 205 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Intervention 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) |
Primary Purpose: | Diagnostic |
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 |
Actual Study Start Date : | May 19, 2021 |
Estimated Primary Completion Date : | March 1, 2023 |
Estimated Study Completion Date : | March 31, 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: Control
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.
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Diagnostic Test: Clinical Trial
Retinal image acquisition with Cellularis version 2.0 |
Experimental: Patient
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.
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Diagnostic Test: Clinical Trial
Retinal image acquisition with Cellularis version 2.0 |
- RPE morphology [ Time Frame: 12 months ]RPE cell density (number of cells per mm^2)
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04912622
Contact: Leila S. Eppenberger, MD, MSc. ETH | +41 41 205 1323 | leila.eppenberger@luks.ch | |
Contact: Martin Schmid, MD, Chief physician |
Switzerland | |
Kantonsspital Luzern | Recruiting |
Lucerne, Switzerland | |
Contact: Leila S. Eppenberger, MD, MSc. ETH +41 41 205 1323 leila.eppenberger@luks.ch |
Responsible Party: | Luzerner Kantonsspital |
ClinicalTrials.gov Identifier: | NCT04912622 |
Other Study ID Numbers: |
Cellularis Studie 01 EKNZ2020-02454 ( Other Identifier: BASEC ) |
First Posted: | June 3, 2021 Key Record Dates |
Last Update Posted: | June 3, 2021 |
Last Verified: | May 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Eye Diseases Retinal Diseases |