RPE Characterisation With Transscleral Optical Phase Imaging in Retinal Disorders

NCT04912622 | Completed

• 2 other identifiers: Cellularis Studie 01EKNZ2020-02454
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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.

Conditions

Retinal Disease; Eye Disease

Outcome Measures

Primary Outcomes (1)

• RPE morphology

  RPE cell density (number of cells per mm\^2)

  12 months

Secondary Outcomes (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

Study Arms (2)

Control

EXPERIMENTAL

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

Patient

EXPERIMENTAL

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

Interventions

Clinical Trial DIAGNOSTIC_TEST

Retinal image acquisition with Cellularis version 2.0

Control; Patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Inability to follow the procedures of the study due to language problems, psychological disorders, dementia etc. of the participant
• Aged \< 18 years.
• Pregnancy
• Epilepsy

Sponsors & Collaborators

• Luzerner Kantonsspital: lead

Study Sites (1)

Kantonsspital Luzern

Lucerne, Switzerland

Location

MeSH Terms

Conditions

Retinal Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Control group: 110 individuals with healthy retina Patient group: 95 individuals with diseased retina Exclusion: age \< 18y, pregnancy, epilepsy, no informed consent

Study Record Dates

• First Submitted: May 28, 2021
• First Posted: June 3, 2021
• Study Start: May 19, 2021
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: March 7, 2023

Record last verified: 2023-03

Locations

CH (1)