SD-OCT Multimodal Analysis in GLaucoma (SOMAL)

May 28, 2026 updated by: University Hospital, Bordeaux

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

109

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Aquitaine
      • Bordeaux, Aquitaine, France, 33000
        • University Bordeaux Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of Bruch's Membrane Opening Minimum Rim Width
Time Frame: 1 day
Diagnostic accuracy of SD-OCT to discriminate perimetric, preperimetric glaucoma patients and control patients
1 day

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluation of Retinal Nerve Fiber Layer Thickness
Time Frame: 1 day
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 22, 2016

Primary Completion (Actual)

December 21, 2018

Study Completion (Actual)

December 21, 2018

Study Registration Dates

First Submitted

March 4, 2016

First Submitted That Met QC Criteria

March 11, 2016

First Posted (Estimated)

March 17, 2016

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 28, 2026

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2015/20
  • 2015-A01708-41 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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