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Retinal Imaging With Oblique Illumination (ASSESS)

Primary Purpose

Retinal Disease

Status

Completed

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

Cellularis version 1 imaging

About this trial

This is an interventional diagnostic trial for Retinal Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Jules Gonin eye hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Arm Label

Group 1

Group 2

Group 3

Group 4

Group 5

Arm Description

Individuals with healthy retina, 18 to 50 years old.

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

Individuals with healthy retina, over the age of 50.

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

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

Outcomes

Primary Outcome Measures

Number RPE [#/mm2]

The primary outcome is the RPE cells density map of the imaged regions (in #/mm2).

Qualitative analysis [unitless]

Together with the quantitative outcomes of the density, a detailed qualitative analysis will also be performed.

Secondary Outcome Measures

averaged RPE cell area [um2]

- The RPE cell area.

Averaged number of neighbors of RPE cells [unitless]

Averaged number of neighbors of RPE cells

Averaged RPE spacing [um]

The averaged RPE spacing in um.

Averaged RPE pigmentation parameter [unitless]

RPE pigmentation parameter at cellular level

Full Information

NCT ID

NCT04398394

First Posted

May 14, 2020

Last Updated

July 6, 2023

Sponsor

Moser Christophe

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France, Eye Hospital Jules Gonin

1. Study Identification

Unique Protocol Identification Number

NCT04398394

Brief Title

Retinal Imaging With Oblique Illumination

Acronym

ASSESS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

August 11, 2020 (Actual)

Primary Completion Date

April 11, 2022 (Actual)

Study Completion Date

April 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Moser Christophe

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France, Eye Hospital Jules Gonin

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Retinal Disease

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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)

Allocation

Non-Randomized

Enrollment

102 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1

Arm Type

Experimental

Arm Description

Individuals with healthy retina, 18 to 50 years old.

Arm Title

Group 2

Arm Type

Experimental

Arm Description

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

Arm Title

Group 3

Arm Type

Experimental

Arm Description

Individuals with healthy retina, over the age of 50.

Arm Title

Group 4

Arm Type

Experimental

Arm Description

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

Arm Title

Group 5

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Cellularis version 1 imaging

Intervention Description

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).

Primary Outcome Measure Information:

Title

Number RPE [#/mm2]

Description

The primary outcome is the RPE cells density map of the imaged regions (in #/mm2).

Time Frame

2 months

Title

Qualitative analysis [unitless]

Description

Together with the quantitative outcomes of the density, a detailed qualitative analysis will also be performed.

Time Frame

2 months

Secondary Outcome Measure Information:

Title

averaged RPE cell area [um2]

Description

- The RPE cell area.

Time Frame

2 months

Title

Averaged number of neighbors of RPE cells [unitless]

Description

Averaged number of neighbors of RPE cells

Time Frame

2 months

Title

Averaged RPE spacing [um]

Description

The averaged RPE spacing in um.

Time Frame

2 months

Title

Averaged RPE pigmentation parameter [unitless]

Description

RPE pigmentation parameter at cellular level

Time Frame

2 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Irmela Mantel, MD

Organizational Affiliation

Jules Gonin eye hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Jules Gonin eye hospital

City

Lausanne

ZIP/Postal Code

1015

Country

Switzerland

12. IPD Sharing Statement

Citations:

PubMed Identifier

36545259

Citation

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.

Results Reference

result

Links:

URL

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

Description

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

Learn more about this trial

Retinal Imaging With Oblique Illumination

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