Retinitis PigmentosaIMA-MODENCT04129021
High Resolution, High-speed Multimodal Ophthalmic Imaging
A study testing High-resolution retinal imaging through adaptive optics and High-resolution retinal imaging through holographic systems in people with Retinitis Pigmentosa and Maculopathy, Age Related, run by Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts at 1 site in France.
Trial summary
Knowledge of the pathogenesis of ocular conditions, a leading cause of blindness, has benefited greatly from recent advances in ophthalmic imaging. However, current clinical imaging systems are limited in resolution, speed, or access to certain structures of the eye. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Retinitis Pigmentosa, Maculopathy, Age Related, Macular Dystrophy
- What is being tested?
- High-resolution retinal imaging through adaptive optics and High-resolution retinal imaging through holographic systems
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jul 2019to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- People over 18
- Patient with a pathology affecting the eye or healthy volunteer
- Participant who signed the consent
- Beneficiaries of the health insurance
Who cannot join
- Patients with a history of photosensitivity.
- Patients who have just received a photodynamic therapy treatment (
- Patients taking drugs with photosensitivity as a side effect.
- Persons with pacemakers or other implanted electronic medical device
- Patients with viral conjunctivitis or any other infectious disease.
- Patients with skin lesions on the neck or forehead
Show all 11Show fewer
- Patients at high risk of damage from optical radiation, such as aphakic patients, or patients with decreased sensitivity to light due to fundus disease.
- Pregnant or lactating women
- Participant unable to be followed throughout the study
- Vulnerable people
- Subjects with predisposition to closure of the iridocorneal angle
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Paris, 75012
Michel PAQUES, PU-PH, 01 40 02 14 15, mpaques@15-20.fr
About this study
Official title: High Resolution and High Speed Multimodal Ophthalmic Imaging
Knowledge of the pathogenesis of ocular conditions, a leading cause of blindness, has benefited greatly from recent advances in ophthalmic imaging. However, current clinical imaging systems are limited in resolution, speed, or access to certain structures of the eye.
The use of a high-resolution imaging system improves the resolution of ophthalmoscopes by several orders of magnitude, allowing the visualization of many microstructures of the eye: photoreceptors, vessels, nerve bundles in the retina, cells and nerves in the cornea.
Read more
The use of a high-speed acquisition imaging system makes it possible to detect functional measurements such as the speed of blood flow. The combination of data from multiple imaging systems to obtain multimodal information is of great importance for improving the understanding of structural changes in the eye during a disease.
The purpose of this project is to observe structures that are not detectable with routinely used systems.
Read the detailed description
The goal of the project is the capture and analysis of images with the IMA-MODE systems, in order to evaluate the performance of these systems compared to the existing clinical imaging devices used at the National Hospital of Ophthalmology.
This project should identify the best techniques to image the eye, and select the most promising techniques to evolve towards a possible development of a medical device.
- Conditions
- Retinitis Pigmentosa, Maculopathy, Age Related, Macular Dystrophy, Macular Edema, Retinal Detachment, Retinal Degeneration
- Being tested
- High-resolution retinal imaging through adaptive optics, High-resolution retinal imaging through holographic systems
- Medical subject headings
- Retinitis Pigmentosa, Macular Degeneration, Macular Edema, Retinal Detachment, Retinal Degeneration, Glaucoma, Hypertension, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-resolution retinal imaging through adaptive opticsDevice
The protocol consists of performing retinal imaging using full-field optical coherence tomography. The participant is asked to put his forehead against the temple supports and his chin on a chin rest. The subject will be asked to fix a test pattern in the form of a cross. The pattern is positioned according to the desired eccentricity with respect to the fovea. The actual acquisition lasts a few seconds, possibly repeated to cover the field of the desired eye. The acquisition protocol depends on the subjects, their pathology and the system used; the area examined will be modified on a case by case basis. The total duration of each exam can be estimated at less than half an hour, with frequent breaks.
High-resolution retinal imaging through holographic systemsDevice
The protocol consists of performing retinal imaging using a laser Doppler holography. For each system, the participant is asked to put his forehead against the temple supports and his chin on a chin rest. The subject will be asked to fix a test pattern in the form of a cross. The pattern is positioned according to the desired eccentricity with respect to the fovea. The actual acquisition lasts a few seconds, possibly repeated to cover the field of the desired eye. The acquisition protocol depends on the subjects, their pathology and the system used; the area examined will be modified on a case by case basis. The total duration of each exam can be estimated at less than half an hour, with frequent breaks.
| Study group | Role | What they receive |
|---|---|---|
| High-resolution retinal imaging through adaptive optics | Experimental | High-resolution retinal imaging through adaptive optics, full field OCT and holographic systems Receives: Device: High-resolution retinal imaging through adaptive optics; Device: High-resolution retinal imaging through holographic systems |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visualization of a structure of interest and measuring the short-term and long-term reproducibility of the data collected compared to routine systems
Obtain the visualization of a structure of interest or obtain a measurement that are not detectable with the systems used routinely by analyzing images with image analysis software dedicated by a multidisciplinary group including doctors and physicists, assisted by computer scientists
The visualization of the structure of interest in at least one area of the image will be considered the main criterion of success.
Measured: From date of inclusion until the date of last documented progression , assessed up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2019
- Study start3 Jul 2019
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Retinitis PigmentosaStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michel PAQUES, Principal investigator, Centre Hospitalier National d'Ophtalmologie des Quinze-Vints
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04129021
- Sponsor's protocol ID
- P19-03
- Other IDs
- 2019-A00942-55
- Acronym
- IMA-MODE
- Status last verified
- Nov 2025
- First submitted
- 19 Aug 2019
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Paques M, Norberg N, Chaumette C, Sennlaub F, Rossi E, Borella Y, Grieve K. Long Term Time-Lapse Imaging of Geographic Atrophy: A Pilot Study. Front Med (Lausanne). 2022 Jun 22;9:868163. doi: 10.3389/fmed.2022.868163. eCollection 2022.
PubMed 35814763
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Resolution and High Speed Multimodal Ophthalmic Imaging
- ClinicalTrials.gov ID
- NCT04129021
- Acronym / sponsor ID
- IMA-MODE / P19-03
- Conditions
- Retinitis Pigmentosa, Maculopathy, Age Related, Macular Dystrophy, Macular Edema, Retinal Detachment, Retinal Degeneration
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Centre Hospitalier National d'Ophtalmologie des Quinze-VingtsUniversity, hospital or other
- Study start
- 3 Jul 2019 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 16 Oct 2019 (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.
Knowledge of the pathogenesis of ocular conditions, a leading cause of blindness, has benefited greatly from recent advances in ophthalmic imaging. However, current clinical imaging systems are limited in resolution, speed, or access to certain structures of the eye.
The use of a high-resolution imaging system improves the resolution of ophthalmoscopes by several orders of magnitude, allowing the visualization of many microstructures of the eye: photoreceptors, vessels, nerve bundles in the retina, cells and nerves in the cornea.
The use of a high-speed acquisition imaging system makes it possible to detect functional measurements such as the speed of blood flow. The combination of data from multiple imaging systems to obtain multimodal information is of great importance for improving the understanding of structural changes in the eye during a disease.
The purpose of this project is to observe structures that are not detectable with routinely used systems.
Detailed description
The goal of the project is the capture and analysis of images with the IMA-MODE systems, in order to evaluate the performance of these systems compared to the existing clinical imaging devices used at the National Hospital of Ophthalmology.
This project should identify the best techniques to image the eye, and select the most promising techniques to evolve towards a possible development of a medical device.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High-resolution retinal imaging through adaptive optics | Experimental | Device: High-resolution retinal imaging through adaptive optics, Device: High-resolution retinal imaging through holographic systemsHigh-resolution retinal imaging through adaptive optics, full field OCT and holographic systems |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- People over 18
- Patient with a pathology affecting the eye or healthy volunteer
- Participant who signed the consent
- Beneficiaries of the health insurance
Key exclusion criteria (11 listed)
- Patients with a history of photosensitivity.
- Patients who have just received a photodynamic therapy treatment (
- Patients taking drugs with photosensitivity as a side effect.
- Persons with pacemakers or other implanted electronic medical device
- Patients with viral conjunctivitis or any other infectious disease.
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 |
|---|---|---|
| High-resolution retinal imaging through adaptive opticsThe protocol consists of performing retinal imaging using full-field optical coherence tomography. The participant is asked to put his forehead against the temple supports and his chin on a chin rest. The subject will be asked to fix a test pattern in the form of a cross. The pattern is positioned according to the desired eccentricity with respect to the fovea. The actual acquisition lasts a few seconds, possibly repeated to cover the field of the desired eye. The acquisition protocol depends on the subjects, their pathology and the system used; the area examined will be modified on a case by case basis. The total duration of each exam can be estimated at less than half an hour, with frequent breaks. | Device | High-resolution retinal imaging through adaptive optics |
| High-resolution retinal imaging through holographic systemsThe protocol consists of performing retinal imaging using a laser Doppler holography. For each system, the participant is asked to put his forehead against the temple supports and his chin on a chin rest. The subject will be asked to fix a test pattern in the form of a cross. The pattern is positioned according to the desired eccentricity with respect to the fovea. The actual acquisition lasts a few seconds, possibly repeated to cover the field of the desired eye. The acquisition protocol depends on the subjects, their pathology and the system used; the area examined will be modified on a case by case basis. The total duration of each exam can be estimated at less than half an hour, with frequent breaks. | Device | High-resolution retinal imaging through adaptive optics |
Primary outcome
Visualization of a structure of interest and measuring the short-term and long-term reproducibility of the data collected compared to routine systems
Time frame: From date of inclusion until the date of last documented progression , assessed up to 5 years
Obtain the visualization of a structure of interest or obtain a measurement that are not detectable with the systems used routinely by analyzing images with image analysis software dedicated by a multidisciplinary group including doctors and physicists, assisted by computer scientists The visualization of the structure of interest in at least one area of the image will be considered the main criterion of success.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Derived from this study: PubMed 35814763Paques M, Norberg N, Chaumette C, Sennlaub F, Rossi E, Borella Y, Grieve K. Long Term Time-Lapse Imaging of Geographic Atrophy: A Pilot Study. Front Med (Lausanne). 2022 Jun 22;9:868163. doi: 10.3389/fmed.2022.868163. eCollection 2022.
Related trials for Retinitis Pigmentosa
RecruitingObservational study
Rod and Cone Mediated Function in Retinal Disease
Retinal Degeneration, Retinitis Pigmentosa
RecruitingPhase 1
Safety of Cultured Allogeneic Adult Umbilical Cord or Placental Derived Mesenchymal Stem Cell Exosomes for NAION
Eye Diseases, Retinitis Pigmentosa
RecruitingEarly Phase 1
Safety and Tolerability Study of Gene Editing Drug ZVS203e in Participants With Retinitis Pigmentosa
Retinitis Pigmentosa
RecruitingPhase 1/2
A Study to Investigate the Safety of OpCT-001 in Adults Who Have Primary Photoreceptor Disease (CLARICO)
Primary Photoreceptor Disease, Retinitis Pigmentosa (RP)
RecruitingPhase 3
A 24-Month Trial of NPI-001 for the Preservation of Photoreceptors in Retinitis Pigmentosa Associated With Usher Syndrome
Retinitis Pigmentosa (RP), Usher Syndrome
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.
Michel PAQUES principal investigator
Centre Hospitalier National d'Ophtalmologie des Quinze-Vints
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-resolution retinal imaging through adaptive optics and High-resolution retinal imaging through holographic systems in people with Retinitis Pigmentosa and Maculopathy, Age Related, run by Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts at 1 site in France.
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 4 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 18 Nov 2025. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nabil BROUK (+33 140021144, nbrouk@15-20.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visualization of a structure of interest and measuring the short-term and long-term reproducibility of the data collected compared to routine systems (time frame: From date of inclusion until the date of last documented progression , assessed up to 5 years). 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 NCT04129021, which also lists 1 linked publication.
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 18 Nov 2025; AzTrials last refreshed its copy on 26 Oct 2026.