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Trial record 60 of 1935 for:    eye disease [DISEASE] AND ( "06/18/2011" : MAX ) [FIRST-RECEIVED-DATE] | Recruiting, Not yet recruiting, Available Studies

RPE Characterisation With Transscleral Optical Phase Imaging in Retinal Disorders (CEL01LUKS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04912622
Recruitment Status : Recruiting
First Posted : June 3, 2021
Last Update Posted : June 3, 2021
Sponsor:
Information provided by (Responsible Party):
Luzerner Kantonsspital

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.

Condition or disease Intervention/treatment Phase
Retinal Disease Eye Disease Diagnostic Test: Clinical Trial Not Applicable

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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.
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.
Diagnostic Test: Clinical Trial
Retinal image acquisition with Cellularis version 2.0




Primary Outcome Measures :
  1. RPE morphology [ Time Frame: 12 months ]
    RPE cell density (number of cells per mm^2)


Secondary Outcome Measures :
  1. 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
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

Information from the National Library of Medicine

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


Contacts
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Contact: Leila S. Eppenberger, MD, MSc. ETH +41 41 205 1323 leila.eppenberger@luks.ch
Contact: Martin Schmid, MD, Chief physician

Locations
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Switzerland
Kantonsspital Luzern Recruiting
Lucerne, Switzerland
Contact: Leila S. Eppenberger, MD, MSc. ETH    +41 41 205 1323    leila.eppenberger@luks.ch   
Sponsors and Collaborators
Luzerner Kantonsspital
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Eye Diseases
Retinal Diseases