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SD-OCT Multimodal Analysis in GLaucoma

NCT02710916 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 109

Last updated 2019-07-08

No results posted yet for this study

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

Interventions

DEVICE

SD-OCT Spectralis

All patients will undergo a complete ophthalmological examination with SD-OCT complete evaluation

Sponsors & Collaborators

  • University Hospital, Bordeaux

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-02-22
Primary Completion
2018-12-21
Completion
2018-12-21

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02710916 on ClinicalTrials.gov