SD-OCT Multimodal Analysis in GLaucoma

NCT02710916 | Completed

• 1 other identifier: CHUBX 2015/20
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Optical Coherence Tomography; Intraocular pressure; Optic Nerve Head; Nerve fiber layer; Bruch Membrane Opening -Minimum Rim Width

Outcome Measures

Primary Outcomes (1)

• Evaluation of Bruch's Membrane Opening Minimum Rim Width

  Diagnostic accuracy of SD-OCT to discriminate perimetric, preperimetric glaucoma patients and control patients

  1 day

Secondary Outcomes (1)

• Evaluation of Retinal Nerve Fiber Layer Thickness

  1 day

Study Arms (3)

perimetric glaucoma patients

SHAM COMPARATOR

Device: SD-OCT Spectralis

preperimetric glaucoma patients

ACTIVE COMPARATOR

Device: SD-OCT Spectralis

perimetric glaucoma control patients

SHAM COMPARATOR

Device: SD-OCT Spectralis

Interventions

SD-OCT Spectralis DEVICE

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

perimetric glaucoma control patients; perimetric glaucoma patients; preperimetric glaucoma patients

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• No history or evidence of retinal pathology or glaucoma
• Normal Humphrey 24-2 Visual Field (VF) : A mean defect (MD), corrected pattern standard deviation (CPSD) within 95% limits of normal reference, and glaucoma hemifield test (GHT) within normal limits (97%).
• Intraocular pressure \< 21 mm Hg
• Open angle (Shaffer's grading system)
• Normal appearing Optic Nerve Hypoplasia (ONH) and Nerve Fiber Layer (NFL) : intact neuroretinal rim without peripapillary hemorrhages, notches, localized pallor, or NFL defect
• Symmetric ONH between left and right eyes: Cup-to-Disc Ratio (CDR) difference \< 0.2 in both vertical and horizontal dimensions
• ONH or NFL defect visible on slit-lamp biomicroscopy defined as one of following:
• diffuse or localized thinning of the rim
• disc (splinter) hemorrhage
• notch in the rim
• vertical cup/disc ratio greater than the fellow eye by \> 0.2
• Consistent glaucomatous pattern on both qualifying Humphrey Swedish Interactive Threshold Algorithm (SITA) 24-2 VF meeting at least one of the following quantitative criteria for abnormality:
• PSD outside normal limits (p \< 0.05)
• GHT outside normal limits (p \< 0.01)
• PPG participants must have at least one eye meeting all of the following criteria:

You may not qualify if:

• Age \< 40
• Refractive error of \> +6.00 D or \< -6.00 D (SE), +3,00 D for astigmatism
• Diabetic retinopathy
• Other diseases that may cause VF loss or optic disc abnormalities
• Inability to clinically view or photograph the optic discs due to media opacity or poorly dilating pupil
• Inability to perform reliably on automated VF testing
• Insufficient quality of Spectralis OCT images (this is not determined until after Spectralis OCT examination, and is an unusual circumstance). Minimum requirements are:
• Retina completely included in image frame,
• Quality Score ≥ 15 in the stored mean images,
• Refusal of informed consent

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

University Bordeaux Hospital

Bordeaux, Aquitaine, 33000, France

Location

Related Publications (26)

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MeSH Terms

Conditions

Glaucoma; Ocular Hypertension; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2016
• First Posted: March 17, 2016
• Study Start: February 22, 2016
• Primary Completion: December 21, 2018
• Study Completion: December 21, 2018
• Last Updated: July 8, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)