NCT02710916

SD-OCT Multimodal Analysis in GLaucoma

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 109 (actual)
• Sponsor: University Hospital, Bordeaux · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Accepted

Summary

Glaucoma is the first cause of irreversible blindness worldwide with more than 60 millions people affected in 2010. It is defined as a neurodegenerative disease characterized by a progressive loss of retinal ganglion cells (RGC), visual field deterioration and optic nerve excavation. Intraocular pressure (IOP) is the most common risk factor. Despite its severity, its impact on quality of life and an existing treatment that can delay visual field damages, there is no recommended strategy to screen the disease. Clinical evaluation of optic nerve head excavation performed either by ophthalmologists or glaucoma specialists is highly inter-observer dependent and limits its accuracy to diagnose glaucoma. Additionally, up to 30 to 40% of nerve fiber layer may be lost before detecting first visual field defects, thus making this tool not accurate enough for screening purposes. Spectral-Domain Optical coherence tomography (SD-OCT) imaging technology allows precise and reproducible measurements of optic nerve head structures and retinal layers mainly related to the speed of acquisition and an axial resolution of 5 microns. New SD-OCT parameters have been developed to improve its diagnostic accuracy for glaucoma disease. The investigators therefore investigate performances of SD-OCT to discriminate glaucoma patients and controls. All subjects will undergo SD-OCT imaging (Spectralis™ OCT, Version 6.3, Heidelberg Engineering, Germany) and other study procedures in one single visit. All examinations performed on the subjects are non-significant risk.

Conditions

• Glaucoma
• Ocular Hypertension
• Eye Diseases

Interventions

Type	Name	Description
DEVICE	SD-OCT Spectralis	All patients will undergo a complete ophthalmological examination with SD-OCT complete evaluation

Timeline

• Start date: 2016-02-22
• Primary completion: 2018-12-21
• Completion: 2018-12-21
• First posted: 2016-03-17
• Last updated: 2019-07-08

Locations

1 site across 1 country: France