NCT06989996

Study of Human Ocular Hemodynamics by Holography Dopple

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 148 (estimated)
• Sponsor: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts · Academic / Other
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Accepted

Summary

Prospective, interventional, non-randomized, open-label study, multi-center, Gehan-designed study with sequential inclusions in each subgroup, ranging from 4 subjects to a maximum 37 subjects per subgroup included

Detailed description

Retinal perfusion can be affected by a number of local or general pathologies; however, there is currently no commercially available device to provide accurate measurements of retinal blood flow. The company Quantel Medical is developing a medical imaging device HoloDoppler (hereinafter referred to as the "HoloDoppler system"). system. In order to better define its medical utility, we aim to evaluate its reproducibility and accuracy in healthy subjects and those with conditions that may affect ocular blood flow.

Conditions

• Glaucoma
• Retinal Vascular Disorder

Interventions

Type	Name	Description
DEVICE	Images Acquisition	Acquisition of useable video images

Timeline

• Start date: 2025-06-01
• Primary completion: 2028-06-01
• Completion: 2028-06-01
• First posted: 2025-05-25
• Last updated: 2025-05-25