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SD-OCT Multimodal Analysis in GLaucoma (SOMAL)

Primary Purpose

Glaucoma, Ocular Hypertension, Eye Diseases

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
SD-OCT Spectralis
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Glaucoma focused on measuring Optical Coherence Tomography, Intraocular pressure, Optic Nerve Head, Nerve fiber layer, Bruch Membrane Opening -Minimum Rim Width

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Normal Subjects

  1. No history or evidence of retinal pathology or glaucoma
  2. 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%).
  3. Intraocular pressure < 21 mm Hg
  4. Open angle (Shaffer's grading system)
  5. Normal appearing Optic Nerve Hypoplasia (ONH) and Nerve Fiber Layer (NFL) : intact neuroretinal rim without peripapillary hemorrhages, notches, localized pallor, or NFL defect
  6. 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

  1. 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

  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:

  1. 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
  2. Baseline VF not meeting the criteria for the PG group.

  3. Risk factors for glaucoma, one of following:

    • Intraocular pressure > 21 mm Hg
    • Ethnics
    • Family history of glaucoma

Exclusion Criteria: All Groups

  1. Age < 40
  2. Refractive error of > +6.00 D or < -6.00 D (SE), +3,00 D for astigmatism
  3. Diabetic retinopathy
  4. Other diseases that may cause VF loss or optic disc abnormalities
  5. Inability to clinically view or photograph the optic discs due to media opacity or poorly dilating pupil
  6. Inability to perform reliably on automated VF testing

  7. 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,
  8. Refusal of informed consent

Sites / Locations

  • University Bordeaux Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Sham Comparator

Active Comparator

Sham Comparator

Arm Label

perimetric glaucoma patients

preperimetric glaucoma patients

perimetric glaucoma control patients

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Evaluation of Retinal Nerve Fiber Layer Thickness

Full Information

First Posted
March 4, 2016
Last Updated
July 4, 2019
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT02710916
Brief Title
SD-OCT Multimodal Analysis in GLaucoma
Acronym
SOMAL
Official Title
SD-OCT Multimodal Analysis in GLaucoma
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
February 22, 2016 (Actual)
Primary Completion Date
December 21, 2018 (Actual)
Study Completion Date
December 21, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Ocular Hypertension, Eye Diseases
Keywords
Optical Coherence Tomography, Intraocular pressure, Optic Nerve Head, Nerve fiber layer, Bruch Membrane Opening -Minimum Rim Width

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
109 (Actual)

8. Arms, Groups, and Interventions

Arm Title
perimetric glaucoma patients
Arm Type
Sham Comparator
Arm Title
preperimetric glaucoma patients
Arm Type
Active Comparator
Arm Title
perimetric glaucoma control patients
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
SD-OCT Spectralis
Intervention Description
All patients will undergo a complete ophthalmological examination with SD-OCT complete evaluation
Primary Outcome Measure Information:
Title
Evaluation of Bruch's Membrane Opening Minimum Rim Width
Description
Diagnostic accuracy of SD-OCT to discriminate perimetric, preperimetric glaucoma patients and control patients
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Evaluation of Retinal Nerve Fiber Layer Thickness
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 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
Facility Information:
Facility Name
University Bordeaux Hospital
City
Bordeaux
State/Province
Aquitaine
ZIP/Postal Code
33000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
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SD-OCT Multimodal Analysis in GLaucoma

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