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| Name | Class |
|---|---|
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
| Eye Hospital Jules Gonin | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Individuals with healthy retina, 18 to 50 years old. |
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| Group 2 | Experimental | Individuals with healthy retina and presenting with myopia, 18 to 50 years old. |
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| Group 3 | Experimental | Individuals with healthy retina, over the age of 50. |
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| Group 4 | Experimental | Patients with early and intermediate AMD, over the age of 50. |
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| Group 5 | Experimental | Patients with other retinopathies than AMD, over the age of 18. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cellularis version 1 imaging | Device | 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). |
| 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 |
| 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 |
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Inclusion Criteria:
Group 1
Group 2
Group 3
Group 4
Group 5
Exclusion Criteria:
Eye with
Individual:
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| Name | Affiliation | Role |
|---|---|---|
| Irmela Mantel, MD | Jules Gonin eye hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jules Gonin eye hospital | Lausanne | 1015 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36545259 | Result | 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. | |
| 40358157 |
| Label | URL |
|---|---|
| Laforest, T., Künzi, M., Kowalczuk, L. et al. Transscleral optical phase imaging of the human retina. Nat. Photonics (2020). | View source |
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| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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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.
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|
| 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 |
| Kowalczuk L, Dornier R, Navarro A, Jeunet F, Moser C, Behar-Cohen F, Mantel I. Adaptive Optics-Transscleral Flood Illumination Imaging of Retinal Pigment Epithelium in Dry Age-Related Macular Degeneration. Cells. 2025 Apr 24;14(9):633. doi: 10.3390/cells14090633. |