Retinal Imaging With Oblique Illumination

Study Overview
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Brief Summary
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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).

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

Conditions
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Retinal Disease

Intervention / Treatment
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* Device: Cellularis version 1 imaging


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Group 1: 20 to 30 individuals with healthy retina, 18 to 50 years old. Group 2: 20 to 30 individuals with healthy retina and presenting with myopia, 18 to 50 years old. Group 3: 20 to 30 individuals with healthy retina, over the age of 50. Group 4: 25 to 50 patients with early and intermediate AMD, over the age of 50. Group 5: 25 to 50 patients with other retinopathies than AMD, over the age of 18.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Individuals with healthy retina, 18 to 50 years old. | Device: Cellularis version 1 imaging<br>* 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).<br>|
| Experimental: Group 2<br>Individuals with healthy retina and presenting with myopia, 18 to 50 years old. | Device: Cellularis version 1 imaging<br>* 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).<br>|
| Experimental: Group 3<br>Individuals with healthy retina, over the age of 50. | Device: Cellularis version 1 imaging<br>* 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).<br>|
| Experimental: Group 4<br>Patients with early and intermediate AMD, over the age of 50. | Device: Cellularis version 1 imaging<br>* 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).<br>|
| Experimental: Group 5<br>Patients with other retinopathies than AMD, over the age of 18. | Device: Cellularis version 1 imaging<br>* 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).<br>|

What is the study measuring?
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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 |