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

Luzerner Kantonsspital

Status: Completed

Conditions: Retinal Disease; Eye Disease

Treatments: Diagnostic Test: Clinical Trial

Study type: Interventional

Funder types: Other

Identifiers

NCT04912622

EKNZ2020-02454 (Other Identifier)

Cellularis Studie 01

Details and patient eligibility

About

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.

Enrollment: 210 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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210 participants in 2 patient groups

Control

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Clinical Trial

Patient

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Clinical Trial