Retinal Imaging With Oblique Illumination

NCT ID: NCT04398394

Last Updated: 2023-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-11
• Study Completion Date: 2022-04-28

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Group 1

Individuals with healthy retina, 18 to 50 years old.

Group Type: EXPERIMENTAL

Cellularis version 1 imaging

Intervention Type: 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).

Group 2

Individuals with healthy retina and presenting with myopia, 18 to 50 years old.

Group Type: EXPERIMENTAL

Cellularis version 1 imaging

Intervention Type: 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).

Group 3

Individuals with healthy retina, over the age of 50.

Group Type: EXPERIMENTAL

Cellularis version 1 imaging

Intervention Type: 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).

Group 4

Patients with early and intermediate AMD, over the age of 50.

Group Type: EXPERIMENTAL

Cellularis version 1 imaging

Intervention Type: 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).

Group 5

Patients with other retinopathies than AMD, over the age of 18.

Group Type: EXPERIMENTAL

Cellularis version 1 imaging

Intervention Type: 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).

Interventions

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).

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role: collaborator

Eye Hospital Jules Gonin

OTHER

Sponsor Role: collaborator

Moser Christophe

OTHER

Sponsor Role: lead

Responsible Party

Moser Christophe

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Irmela Mantel, MD

Role: PRINCIPAL_INVESTIGATOR

Jules Gonin eye hospital

Locations

Jules Gonin eye hospital

Lausanne, , Switzerland

Countries

Switzerland

References

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.

Reference Type: RESULT

PMID: 36545259 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 40358157 (View on PubMed)

Related Links

https://doi.org/10.1038/s41566-020-0608-y

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

Other Identifiers

2019-00429

Identifier Type: -

Identifier Source: org_study_id