NCT04398394

Retinal Imaging With Oblique Illumination

Single Centre Study: Investigational Medical Device of Transscleral Optical Phase Imaging for Retinal Imaging in Healthy Eyes and Retinal Pathology.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Moser Christophe · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Retinal diseases are the major cause of blindness in industrialized countries and while tremendous effort is made to develop novel therapeutic strategies to rescue retinal cells, optimal means to evaluate the effects of such treatments is still missing. Nowadays, diseases diagnosis and treatment monitoring are performed thanks to imaging devices and functional measurements (visual acuity of visual field tests). These eye examinations lead to the detection of large scale damages of the retinal tissue, i.e. the diagnosis is made too late or the treatments cannot be adapted in time. With the developed technology, the goal is to provide a tool to the ophthalmologists that allow for better treatment monitoring and early diagnosis. Indeed, the technology is able to image the retinal tissues with a ten times more detailed visualization as compared to the standard of care (OCT instruments, SLO instruments or eye fundus cameras). Towards this goal, we designed the present protocol in order to test the technology with a clinical prototype (Cellularis version 1) in a clinical environment. The objective is to describe and quantify at the cellular level the retina of patient affected by different retinal diseases as well as the healthy retina of people with different ages. We will assess the repeatability of the instrument and compare the results of the measurements with images obtained with the standard of care (OCT and SLO images).

Conditions

• Retinal Disease

Interventions

Type	Name	Description
DEVICE	Cellularis version 1 imaging	Using a new modality for retinal cell imaging, we aim at comparing qualitatively and quantitatively, the morphology of the deepest layer of the retina, the retinal pigment epithelium (RPE) by imaging the people with a prototype instrument (Cellularis version 1).

Timeline

• Start date: 2020-08-11
• Primary completion: 2022-04-11
• Completion: 2022-04-28
• First posted: 2020-05-21
• Last updated: 2023-07-10

Locations

1 site across 1 country: Switzerland