Retinal DiseaseCEL01LUKSNCT04912622
RPE Characterisation With Transscleral Optical Phase Imaging in Retinal Disorders
A study testing Clinical Trial in people with Retinal Disease and Eye Disease, run by Luzerner Kantonsspital at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Retinal Disease, Eye Disease
- What is being tested?
- Clinical Trial
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteSwitzerland
- Study dates
- 19 May 2021to 31 Oct 2022
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Inability to follow the procedures of the study due to language problems, psychological disorders, dementia etc. of the participant
- Aged < 18 years.
- Pregnancy
- Epilepsy
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Retinal Disease, Eye Disease
- Being tested
- Clinical Trial
- Medical subject headings
- Retinal Diseases, Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical TrialDiagnostic test
Retinal image acquisition with Cellularis version 2.0
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | 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. Receives: Diagnostic Test: Clinical Trial |
| Patient | Experimental | 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. Receives: Diagnostic Test: Clinical Trial |
What is being measured
The primary outcome is the main question the study is designed to answer.
RPE morphology
RPE cell density (number of cells per mm^2)
Measured: 12 months
Secondary outcomes (1)
averaged RPE cell area [um2] Averaged number of neighbors of RPE cells [unitless] Averaged RPE spacing [um] Averaged RPE pigmentation parameter [unitless]
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study start19 May 2021
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luzerner Kantonsspital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04912622
- Sponsor's protocol ID
- Cellularis Studie 01
- Other IDs
- EKNZ2020-02454
- Acronym
- CEL01LUKS
- Status last verified
- Mar 2023
- First submitted
- 28 May 2021
- Last updated
- 7 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04912622
- Acronym / sponsor ID
- CEL01LUKS / Cellularis Studie 01
- Conditions
- Retinal Disease, Eye Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Luzerner KantonsspitalUniversity, hospital or other
- Study start
- 19 May 2021 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 3 Jun 2021 (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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Control group: 110 individuals with healthy retina Patient group: 95 individuals with diseased retina Exclusion: age < 18y, pregnancy, epilepsy, no informed consent
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Diagnostic Test: Clinical TrialDevice: 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. |
| Patient | Experimental | Diagnostic Test: Clinical TrialDevice: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Inability to follow the procedures of the study due to language problems, psychological disorders, dementia etc. of the participant
- Aged < 18 years.
- Pregnancy
- 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 |
|---|---|---|
| Clinical TrialRetinal image acquisition with Cellularis version 2.0 | Diagnostic test | Control, Patient |
Primary outcome
RPE morphology
Time frame: 12 months
RPE cell density (number of cells per mm^2)
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical Trial in people with Retinal Disease and Eye Disease, run by Luzerner Kantonsspital 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 4 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: finished, as of the sponsor's last update on 7 Mar 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RPE morphology (time frame: 12 months). 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 7 Mar 2023.