RPE Characterisation With Transscleral Optical Phase Imaging in Retinal Disorders

Not Applicable

Completed

• Conditions: Eye Disease; Retinal Disease
• Interventions: Diagnostic Test: Clinical Trial

• Registration Number: NCT04912622
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-19
• Study First Submitted: 2021-05-28
• Study First Submitted QC: 2021-05-28
• Study First Posted: 2021-06-03
• Primary Completion: 2022-10-31
• Study Completion: 2022-10-31
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-06
• Last Update Posted: 2023-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Clinical Trial	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.
Patient	Clinical Trial	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.

Primary Outcome Measures

Name	Time	Method
RPE morphology	12 months	RPE cell density (number of cells per mm\^2)

Secondary Outcome Measures

Name	Time	Method
averaged RPE cell area [um2] Averaged number of neighbors of RPE cells [unitless] Averaged RPE spacing [um] Averaged RPE pigmentation parameter [unitless]	12 months

Trial Locations

Locations (1)

Kantonsspital Luzern; 🇨🇭 Lucerne, Switzerland