Clinical trial NCT04129021: High Resolution, High-speed Multimodal Ophthalmic Imaging
Official title: High Resolution and High Speed Multimodal Ophthalmic Imaging
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: 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
Lead sponsor: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Sponsor class: OTHER
First posted: 2019-10-16
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: 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:

* 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

Primary outcomes:
measure: Visualization of a structure of interest and measuring the short-term and long-term reproducibility of the data collected compared to routine systems
timeFrame: From date of inclusion until the date of last documented progression , assessed up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Study officials:
affiliation: Centre Hospitalier National d'Ophtalmologie des Quinze-Vints
name: Michel PAQUES
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.