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OpenTrials
Completed

NCT Number: NCT04912622

RPE Characterisation With Transscleral Optical Phase Imaging in Retinal Disorders

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.

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Key information

Conditions

Retinal Disease Eye Disease Eye Diseases Retinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kantonsspital Luzern

Lucerne, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clinical Trial

Diagnostic Test

Retinal image acquisition with Cellularis version 2.0

Primary outcomes

  1. RPE morphology

    Time frame: 12 months

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

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]

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Luzerner Kantonsspital

Other

Registry information

Official study 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

Acronym: CEL01LUKS

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 3, 2021
Registry last updated
Mar 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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