NCT04398394: ASSESS

Retinal Imaging With Oblique Illumination

Completed NA Last updated 10 July 2023

What this trial tests

NA trial testing Cellularis version 1 imaging in Retinal Disease in 102 participants. Completed in 28 April 2022.

Timeline

11 August 2020

Primary endpoint
11 April 2022

28 April 2022

Quick facts

Lead sponsor	Moser Christophe
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	102
Start date	11 August 2020
Primary completion	11 April 2022
Estimated completion	28 April 2022
Sites	1 location across Switzerland

Drugs / interventions tested

• Cellularis version 1 imaging

Conditions studied

• Retinal Disease — all drugs for Retinal Disease →

Sponsor

Moser Christophe

Who can join

18 and older, any sex, with Retinal Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. In Vivo Retinal Pigment Epithelium Imaging using Transscleral Optical Imaging in Healthy Eyes.
   Kowalczuk L, Dornier R, Kunzi M, Iskandar A, et al · · 2023 · cited 14× · PMID 36545259 · DOI 10.1016/j.xops.2022.100234
2. Adaptive Optics-Transscleral Flood Illumination Imaging of Retinal Pigment Epithelium in Dry Age-Related Macular Degeneration.
   Kowalczuk L, Dornier R, Navarro A, Jeunet F, et al · · 2025 · cited 1× · PMID 40358157 · DOI 10.3390/cells14090633