Retinal Imaging With Oblique Illumination (ASSESS)

July 6, 2023 updated by: Moser Christophe

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
102

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Lausanne, Switzerland, 1015
        • Jules Gonin eye hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group 1
Individuals with healthy retina, 18 to 50 years old.
Device: 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).
Experimental: Group 2
Individuals with healthy retina and presenting with myopia, 18 to 50 years old.
Device: 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).
Experimental: Group 3
Individuals with healthy retina, over the age of 50.
Device: 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).
Experimental: Group 4
Patients with early and intermediate AMD, over the age of 50.
Device: 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).
Experimental: Group 5
Patients with other retinopathies than AMD, over the age of 18.
Device: 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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number RPE [#/mm2]
Time Frame: 2 months
The primary outcome is the RPE cells density map of the imaged regions (in #/mm2).
2 months
Qualitative analysis [unitless]
Time Frame: 2 months
Together with the quantitative outcomes of the density, a detailed qualitative analysis will also be performed.
2 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
averaged RPE cell area [um2]
Time Frame: 2 months
- The RPE cell area.
2 months
Averaged number of neighbors of RPE cells [unitless]
Time Frame: 2 months
Averaged number of neighbors of RPE cells
2 months
Averaged RPE spacing [um]
Time Frame: 2 months
The averaged RPE spacing in um.
2 months
Averaged RPE pigmentation parameter [unitless]
Time Frame: 2 months
RPE pigmentation parameter at cellular level
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Moser Christophe

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Institut National de la Santé Et de la Recherche Médicale, France
Eye Hospital Jules Gonin

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Irmela Mantel, MD, Jules Gonin eye hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 11, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 11, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 28, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 14, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 21, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 10, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2019-00429

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings