Retinal DiseaseASSESSNCT04398394
Retinal Imaging With Oblique Illumination
A study testing Cellularis version 1 imaging in people with Retinal Disease, run by Moser Christophe at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Retinal Disease
- What is being tested?
- Cellularis version 1 imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteSwitzerland
- Study dates
- 11 Aug 2020to 28 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- Retinal Disease
- Being tested
- Cellularis version 1 imaging
- Medical subject headings
- Retinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Individuals with healthy retina, 18 to 50 years old. Receives: Device: Cellularis version 1 imaging |
| Group 2 | Experimental | Individuals with healthy retina and presenting with myopia, 18 to 50 years old. Receives: Device: Cellularis version 1 imaging |
| Group 3 | Experimental | Individuals with healthy retina, over the age of 50. Receives: Device: Cellularis version 1 imaging |
| Group 4 | Experimental | Patients with early and intermediate AMD, over the age of 50. Receives: Device: Cellularis version 1 imaging |
| Group 5 | Experimental | Patients with other retinopathies than AMD, over the age of 18. Receives: Device: Cellularis version 1 imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number RPE [#/mm2]
The primary outcome is the RPE cells density map of the imaged regions (in #/mm2).
Measured: 2 months
Qualitative analysis [unitless]
Together with the quantitative outcomes of the density, a detailed qualitative analysis will also be performed.
Measured: 2 months
Secondary outcomes (4)
averaged RPE cell area [um2]
- The RPE cell area.
Measured: 2 months
Averaged number of neighbors of RPE cells [unitless]
Averaged number of neighbors of RPE cells
Measured: 2 months
Averaged RPE spacing [um]
The averaged RPE spacing in um.
Measured: 2 months
Averaged RPE pigmentation parameter [unitless]
RPE pigmentation parameter at cellular level
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start11 Aug 2020
- Primary completion11 Apr 2022
- Study completion28 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Retinal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moser Christophe
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, Eye Hospital Jules Gonin
- Responsible party
- Sponsor-investigator, Moser Christophe, Ecole Polytechnique Fédérale de Lausanne
- Investigators
- Irmela Mantel, MD, Principal investigator, Jules Gonin eye hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04398394
- Sponsor's protocol ID
- 2019-00429
- Other IDs
- 2019
- Acronym
- ASSESS
- Status last verified
- Jul 2023
- First submitted
- 14 May 2020
- Last updated
- 10 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36545259Kowalczuk 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.
PubMed 40358157
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Centre Study: Investigational Medical Device of Transscleral Optical Phase Imaging for Retinal Imaging in Healthy Eyes and Retinal Pathology.
- ClinicalTrials.gov ID
- NCT04398394
- Acronym / sponsor ID
- ASSESS / 2019-00429
- Conditions
- Retinal Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Moser ChristopheUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, Eye Hospital Jules Gonin
- Study start
- 11 Aug 2020 (actual)
- Primary completion
- 11 Apr 2022 (actual)
- Study completion
- 28 Apr 2022 (actual)
- First posted
- 21 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Device: Cellularis version 1 imagingIndividuals with healthy retina, 18 to 50 years old. |
| Group 2 | Experimental | Device: Cellularis version 1 imagingIndividuals with healthy retina and presenting with myopia, 18 to 50 years old. |
| Group 3 | Experimental | Device: Cellularis version 1 imagingIndividuals with healthy retina, over the age of 50. |
| Group 4 | Experimental | Device: Cellularis version 1 imagingPatients with early and intermediate AMD, over the age of 50. |
| Group 5 | Experimental | Device: Cellularis version 1 imagingPatients with other retinopathies than AMD, over the age of 18. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cellularis version 1 imagingUsing 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). | Device | Group 1, Group 2, Group 3, Group 4, Group 5 |
Primary outcome
Number RPE [#/mm2]
Time frame: 2 months
The primary outcome is the RPE cells density map of the imaged regions (in #/mm2).
Qualitative analysis [unitless]
Time frame: 2 months
Together with the quantitative outcomes of the density, a detailed qualitative analysis will also be performed.
4 secondary outcomes
averaged RPE cell area [um2]
Time frame: 2 months
Averaged number of neighbors of RPE cells [unitless]
Time frame: 2 months
Averaged RPE spacing [um]
Time frame: 2 months
Averaged RPE pigmentation parameter [unitless]
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2023.
- Results publication: PubMed 36545259Kowalczuk 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.
- Derived from this study: PubMed 40358157Kowalczuk 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.
- Laforest, T., Künzi, M., Kowalczuk, L. et al. Transscleral optical phase imaging of the human retina. Nat. Photonics (2020).Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irmela Mantel, MD principal investigator
Jules Gonin eye hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cellularis version 1 imaging in people with Retinal Disease, run by Moser Christophe at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number RPE [#/mm2] (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04398394, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2023.