RPE Characterisation With Transscleral Optical Phase Imaging in Retinal Disorders

Retinal Disease Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04912622
• Other study ID #: Cellularis Studie 01
• Secondary ID: EKNZ2020-02454
• Status: Completed
• Phase: N/A
• Start date: May 19, 2021
• Est. completion date: October 31, 2022

Study information

• Verified date: March 2023
• Source: Luzerner Kantonsspital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: October 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Eye Disease
• Eye Diseases
• Retinal Disease
• Retinal Diseases

Intervention

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

Locations

Country	Name	City	State
Switzerland	Kantonsspital Luzern	Lucerne

Sponsors (1)

Lead Sponsor	Collaborator
Luzerner Kantonsspital

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RPE morphology	RPE cell density (number of cells per mm^2)	12 months
Secondary	averaged RPE cell area [um2] Averaged number of neighbors of RPE cells [unitless] Averaged RPE spacing [um] Averaged RPE pigmentation parameter [unitless]		12 months