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RecruitingNCT04129021IMA-MODEUpdated Nov 18, 2025

High Resolution, High-speed Multimodal Ophthalmic Imaging

An interventional study of High-resolution retinal imaging through adaptive optics and High-resolution retinal imaging through holographic systems in Retinitis Pigmentosa, Maculopathy, Age Related and Macular Dystrophy, sponsored by Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts. Recruiting at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-18.

Sponsored by Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Jul 2019; still recruiting 7 years 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
1,200
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

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.

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.

02

Conditions studied

  • Retinitis Pigmentosa
  • Maculopathy, Age Related
  • Macular Dystrophy
  • Macular Edema
  • Retinal Detachment
  • Retinal Degeneration
  • Glaucoma
  • Vascular Inflammation
  • Hypertension
  • Stroke
  • Diabetes
  • Corneal Dystrophy
  • Keratoconus
  • Dry Eye
  • Trauma
03

In context

Retinitis Pigmentosa

278 studies on the registry are indexed under Retinitis Pigmentosa; 72 are open to participants now.

This study's planned enrollment of 1,200 is above the median of 27 across 179 interventional studies indexed under Retinitis Pigmentosa.

Browse Retinitis Pigmentosa studies →

Lead sponsor

Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts is the lead sponsor of 28 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • People over 18
  • Patient with a pathology affecting the eye or healthy volunteer
  • Participant who signed the consent
  • Beneficiaries of the health insurance

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
1,200 participants (estimated)

Study arms

  • Experimental
    High-resolution retinal imaging through adaptive optics

    High-resolution retinal imaging through adaptive optics, full field OCT and holographic systems

    Device: High-resolution retinal imaging through adaptive optics · Device: High-resolution retinal imaging through holographic systems

Interventions

  • DeviceHigh-resolution retinal imaging through adaptive optics

    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.

  • DeviceHigh-resolution retinal imaging through holographic systems

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From date of inclusion until the date of last documented progression , assessed up to 5 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04129021
Lead sponsor
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Responsible party
Sponsor
First posted
Oct 16, 2019
Start date
Jul 3, 2019
Primary completion
Jul 2027 (estimated)
Completion
Jul 2027 (estimated)
Last update
Nov 18, 2025

Study contacts

Nabil BROUK
Contact
nbrouk@15-20.fr
+33 140021144
Azedine DJABALI
Contact
Adjabali@15-20.fr
+33 140021126
Michel PAQUES
principal investigator · Centre Hospitalier National d'Ophtalmologie des Quinze-Vints

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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