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CEL01LUKS: RPE Characterisation With Transscleral Optical Phase Imaging in Retinal Disorders

Sponsor
Luzerner Kantonsspital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04912622
Collaborator
(none)
205
Enrollment
1
Location
2
Arms
22.4
Anticipated Duration (Months)
9.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Clinical Trial
 N/A

Study Design

Study Type:
Interventional
Anticipated 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 consentControl 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
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Mar 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. RPE morphology [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] [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kantonsspital Luzern Lucerne Switzerland

Sponsors and Collaborators

  • Luzerner Kantonsspital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Luzerner Kantonsspital
ClinicalTrials.gov Identifier:
NCT04912622
Other Study ID Numbers:
  • Cellularis Studie 01
  • EKNZ2020-02454
First Posted:
Jun 3, 2021
Last Update Posted:
Jun 3, 2021
Last Verified:
May 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Eye Diseases
Retinal Diseases

Study Results

No Results Posted as of Jun 3, 2021