NCT04398394

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 21, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

August 11, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 11, 2022

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2022

Completed
Last Updated

July 10, 2023

Status Verified

July 1, 2023

Enrollment Period

1.7 years

First QC Date

May 14, 2020

Last Update Submit

July 6, 2023

Conditions

Retinal Disease

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • averaged RPE cell area [um2]

    2 months

  • Averaged number of neighbors of RPE cells [unitless]

    2 months

  • Averaged RPE spacing [um]

    2 months

  • Averaged RPE pigmentation parameter [unitless]

    2 months

Study Arms (5)

Group 1

EXPERIMENTAL

Individuals with healthy retina, 18 to 50 years old.

Device: Cellularis version 1 imaging

Group 2

EXPERIMENTAL

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

Device: Cellularis version 1 imaging

Group 3

EXPERIMENTAL

Individuals with healthy retina, over the age of 50.

Device: Cellularis version 1 imaging

Group 4

EXPERIMENTAL

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

Device: Cellularis version 1 imaging

Group 5

EXPERIMENTAL

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

Device: Cellularis version 1 imaging

Interventions

Cellularis version 1 imagingDEVICE

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 1Group 2Group 3Group 4Group 5

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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,
  • +1 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jules Gonin eye hospital

Lausanne, 1015, Switzerland

Location

Related Publications (2)

  • 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.

    PMID: 36545259RESULT

  • 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.

    PMID: 40358157DERIVED

Related Links

MeSH Terms

Conditions

Retinal Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

  • Irmela Mantel, MD

    Jules Gonin eye hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 14, 2020

First Posted

May 21, 2020

Study Start

August 11, 2020

Primary Completion

April 11, 2022

Study Completion

April 28, 2022

Last Updated

July 10, 2023

Record last verified: 2023-07

Locations

CH(1)