RPE Characterisation With Transscleral Optical Phase Imaging in Retinal Disorders

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04912622

Acronym

CEL01LUKS

Enrollment

210

Registered

2021-06-03

Start date

2021-05-19

Completion date

2022-10-31

Last updated

2023-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eye Disease, Retinal Disease

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.

Interventions

DIAGNOSTIC_TESTClinical Trial

Retinal image acquisition with Cellularis version 2.0

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

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

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
RPE morphology	12 months	RPE cell density (number of cells per mm\^2)

Secondary

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

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026