Retinal Imaging With Oblique Illumination (ASSESS)

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

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).

Study Overview

• Status: Completed
• Conditions: Retinal Disease
• Intervention / Treatment: Device: Cellularis version 1 imaging

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Lausanne, Switzerland, 1015
    • Jules Gonin eye hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Group 1

• Individuals, 18 to 50 yo, with normal eye fundus.
• Emmetropic or ametropic between +3D and -3D

Group 2

• Individuals, 18 to 50 yo, with normal eye fundus.
• Myopic between -6D and -12D.

Group 3

• Individuals over the age of 50 and age-matched to patients with AMD.
• With nwith normal eye fundus.
• Astigmatic, myopic (<-12D) or presbyopic participants may be included

Group 4

• Patient over 50 yo, with early or intermediate AMD, including extrafoveolar geographic atrophy
• with visual acuity ≥ 0.6 and clinical judgment of good central fixation.

Group 5

• Patient over 18, with other retinopathy than AMD,
• with visual acuity ≥ 0.6 and nd clinical judgment of good fixation

Exclusion Criteria:

Eye with

• RPE detachment
• a clinically unclear situation
• abnormality preventing good visualization of the fundus
• less than 3 months post-surgery of the anterior segment
• less than 6 months post-surgery of the posterior segment
• active uveitis - myopia ≥12D, hyperopia > +5D, astigmatism > 4D
• contraindication to dilatation
• a palpebral opening that is less than 6 mm in height

Individual:

• albino - unable to fix a target at least 10 seconds
• who does not tolerate being in the dark for 30 minutes
• unable to follow the procedures of the study
• refusing to be informed of the incidental discovery of a clinically significant pathology Investigators of the study, their family members, collaborators and students

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; Individuals with healthy retina, 18 to 50 years old.	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).
Experimental: Group 2; Individuals with healthy retina and presenting with myopia, 18 to 50 years old.	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).
Experimental: Group 3; Individuals with healthy retina, over the age of 50.	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).
Experimental: Group 4; Patients with early and intermediate AMD, over the age of 50.	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).
Experimental: Group 5; Patients with other retinopathies than AMD, over the age of 18.	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number RPE [#/mm2]	The primary outcome is the RPE cells density map of the imaged regions (in #/mm2).	2 months
Qualitative analysis [unitless]	Together with the quantitative outcomes of the density, a detailed qualitative analysis will also be performed.	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
averaged RPE cell area [um2]	- The RPE cell area.	2 months
Averaged number of neighbors of RPE cells [unitless]	Averaged number of neighbors of RPE cells	2 months
Averaged RPE spacing [um]	The averaged RPE spacing in um.	2 months
Averaged RPE pigmentation parameter [unitless]	RPE pigmentation parameter at cellular level	2 months

Collaborators and Investigators

• Sponsor: Moser Christophe
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France; Eye Hospital Jules Gonin
• Investigators: Principal Investigator: Irmela Mantel, MD, Jules Gonin eye hospital

Publications and helpful links

General Publications

• Kowalczuk L, Dornier R, Kunzi M, Iskandar A, Misutkova Z, Gryczka A, Navarro A, Jeunet F, Mantel I, Behar-Cohen F, Laforest T, Moser C. In Vivo Retinal Pigment Epithelium Imaging using Transscleral Optical Imaging in Healthy Eyes. Ophthalmol Sci. 2022 Oct 19;3(1):100234. doi: 10.1016/j.xops.2022.100234. eCollection 2023 Mar.

Helpful Links

• Laforest, T., Künzi, M., Kowalczuk, L. et al. Transscleral optical phase imaging of the human retina. Nat. Photonics (2020).

Study record dates

Study Major Dates

• Study Start (Actual): August 11, 2020
• Primary Completion (Actual): April 11, 2022
• Study Completion (Actual): April 28, 2022

Study Registration Dates

• First Submitted: May 14, 2020
• First Submitted That Met QC Criteria: May 20, 2020
• First Posted (Actual): May 21, 2020

Study Record Updates

• Last Update Posted (Actual): July 10, 2023
• Last Update Submitted That Met QC Criteria: July 6, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases
• Other Study ID Numbers: 2019-00429

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No