SOMAL: SD-OCT Multimodal Analysis in GLaucoma

Sponsor

University Hospital, Bordeaux (Other)

Overall Status

Completed

CT.gov ID

NCT02710916

Collaborator

(none)

109

Enrollment

Location

Arms

33.9

Actual Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma Ocular Hypertension Eye Diseases	Device: SD-OCT Spectralis	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

109 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Diagnostic

Official Title:

SD-OCT Multimodal Analysis in GLaucoma

Actual Study Start Date :

Feb 22, 2016

Actual Primary Completion Date :

Dec 21, 2018

Actual Study Completion Date :

Dec 21, 2018

Arms and Interventions

Arm	Intervention/Treatment
Sham Comparator: perimetric glaucoma patients	Device: SD-OCT Spectralis All patients will undergo a complete ophthalmological examination with SD-OCT complete evaluation
Active Comparator: preperimetric glaucoma patients	Device: SD-OCT Spectralis All patients will undergo a complete ophthalmological examination with SD-OCT complete evaluation
Sham Comparator: perimetric glaucoma control patients	Device: SD-OCT Spectralis All patients will undergo a complete ophthalmological examination with SD-OCT complete evaluation

Arm

Intervention/Treatment

Sham Comparator: perimetric glaucoma patients

Device: SD-OCT Spectralis

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

Active Comparator: preperimetric glaucoma patients

Device: SD-OCT Spectralis

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

Sham Comparator: perimetric glaucoma control patients

Device: SD-OCT Spectralis

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

Outcome Measures

Primary Outcome Measures

Evaluation of Bruch's Membrane Opening Minimum Rim Width [1 day]
Diagnostic accuracy of SD-OCT to discriminate perimetric, preperimetric glaucoma patients and control patients

Secondary Outcome Measures

Evaluation of Retinal Nerve Fiber Layer Thickness [1 day]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria: Normal Subjects

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

Inclusion Criteria: Perimetric Glaucoma

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)

Inclusion Criteria: Pre-Perimetric Glaucoma (PPG)

PPG participants must have at least one eye meeting all of the following criteria:

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
well-defined peripapillary NFL bundle defect.
inter-eye vertical CDR asymmetry > 0.2

Baseline VF not meeting the criteria for the PG group.
Risk factors for glaucoma, one of following:

Intraocular pressure > 21 mm Hg
Ethnics
Family history of glaucoma

Exclusion Criteria: All Groups

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