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AzTrials

GlaucomaSOMALNCT02710916

SD-OCT Multimodal Analysis in GLaucoma

A study testing SD-OCT Spectralis in people with Glaucoma and Ocular Hypertension, run by University Hospital, Bordeaux at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 years and olderHealthy volunteers can take part
Conditions the study is for
Glaucoma, Ocular Hypertension, Eye Diseases
What is being tested?
SD-OCT Spectralis
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
109 participants
Where
1 siteFrance
Study dates
22 Feb 2016to 21 Dec 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 26Show fewer
  • 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:
  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • University Bordeaux Hospital

    Bordeaux, Aquitaine, 33000

Other trials in France

About this study

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.

Being tested
SD-OCT Spectralis
Keywords
Optical Coherence Tomography, Intraocular pressure, Optic Nerve Head, Nerve fiber layer, Bruch Membrane Opening -Minimum Rim Width
Medical subject headings
Glaucoma, Ocular Hypertension, Eye Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SD-OCT SpectralisDevice

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

Study groups in NCT02710916
Study groupRoleWhat they receive
perimetric glaucoma patientsSham comparatorNot described
Receives: Device: SD-OCT Spectralis
preperimetric glaucoma patientsActive comparatorNot described
Receives: Device: SD-OCT Spectralis
perimetric glaucoma control patientsSham comparatorNot described
Receives: Device: SD-OCT Spectralis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluation of Bruch's Membrane Opening Minimum Rim Width

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

    Measured: 1 day

Secondary outcomes (1)

  1. Evaluation of Retinal Nerve Fiber Layer Thickness

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2016 (estimated)
  2. Study start22 Feb 2016
  3. Primary completion21 Dec 2018
  4. Study completion21 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
109 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02710916
Sponsor's protocol ID
CHUBX 2015/20
Other IDs
2015-A01708-41
Acronym
SOMAL
Status last verified
Jul 2019
First submitted
4 Mar 2016
Last updated
29 May 2026
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Weinreb RN, Khaw PT. Primary open-angle glaucoma. Lancet. 2004 May 22;363(9422):1711-20. doi: 10.1016/S0140-6736(04)16257-0.

    PubMed 15158634

  • Klein BE, Klein R, Sponsel WE, Franke T, Cantor LB, Martone J, Menage MJ. Prevalence of glaucoma. The Beaver Dam Eye Study. Ophthalmology. 1992 Oct;99(10):1499-504. doi: 10.1016/s0161-6420(92)31774-9.

    PubMed 1454314

  • Sommer A, Tielsch JM, Katz J, Quigley HA, Gottsch JD, Javitt J, Singh K. Relationship between intraocular pressure and primary open angle glaucoma among white and black Americans. The Baltimore Eye Survey. Arch Ophthalmol. 1991 Aug;109(8):1090-5. doi: 10.1001/archopht.1991.01080080050026.

    PubMed 1867550

  • Leibowitz HM, Krueger DE, Maunder LR, Milton RC, Kini MM, Kahn HA, Nickerson RJ, Pool J, Colton TL, Ganley JP, Loewenstein JI, Dawber TR. The Framingham Eye Study monograph: An ophthalmological and epidemiological study of cataract, glaucoma, diabetic retinopathy, macular degeneration, and visual acuity in a general population of 2631 adults, 1973-1975. Surv Ophthalmol. 1980 May-Jun;24(Suppl):335-610.

    PubMed 7444756

  • Leung CK, Lam S, Weinreb RN, Liu S, Ye C, Liu L, He J, Lai GW, Li T, Lam DS. Retinal nerve fiber layer imaging with spectral-domain optical coherence tomography: analysis of the retinal nerve fiber layer map for glaucoma detection. Ophthalmology. 2010 Sep;117(9):1684-91. doi: 10.1016/j.ophtha.2010.01.026. Epub 2010 Jul 21.

    PubMed 20663563

  • Leung CK, Choi N, Weinreb RN, Liu S, Ye C, Liu L, Lai GW, Lau J, Lam DS. Retinal nerve fiber layer imaging with spectral-domain optical coherence tomography: pattern of RNFL defects in glaucoma. Ophthalmology. 2010 Dec;117(12):2337-44. doi: 10.1016/j.ophtha.2010.04.002. Epub 2010 Aug 3.

    PubMed 20678802

  • Windisch BK, Harasymowycz PJ, See JL, Chauhan BC, Belliveau AC, Hutchison DM, Nicolela MT. Comparison between confocal scanning laser tomography, scanning laser polarimetry and optical coherence tomography on the ability to detect localised retinal nerve fibre layer defects in glaucoma patients. Br J Ophthalmol. 2009 Feb;93(2):225-30. doi: 10.1136/bjo.2008.141945. Epub 2008 Sep 2.

    PubMed 18765430

  • Alasil T, Wang K, Yu F, Field MG, Lee H, Baniasadi N, de Boer JF, Coleman AL, Chen TC. Correlation of retinal nerve fiber layer thickness and visual fields in glaucoma: a broken stick model. Am J Ophthalmol. 2014 May;157(5):953-59. doi: 10.1016/j.ajo.2014.01.014. Epub 2014 Jan 30.

    PubMed 24487047

  • Horn FK, Mardin CY, Laemmer R, Baleanu D, Juenemann AM, Kruse FE, Tornow RP. Correlation between local glaucomatous visual field defects and loss of nerve fiber layer thickness measured with polarimetry and spectral domain OCT. Invest Ophthalmol Vis Sci. 2009 May;50(5):1971-7. doi: 10.1167/iovs.08-2405. Epub 2009 Jan 17.

    PubMed 19151389

  • Leaney J, Healey PR, Lee M, Graham SL. Correlation of structural retinal nerve fibre layer parameters and functional measures using Heidelberg Retinal Tomography and Spectralis spectral domain optical coherence tomography at different levels of glaucoma severity. Clin Exp Ophthalmol. 2012 Nov;40(8):802-12. doi: 10.1111/j.1442-9071.2012.02807.x. Epub 2012 Jul 2.

    PubMed 22594488

  • Chauhan BC, O'Leary N, AlMobarak FA, Reis ASC, Yang H, Sharpe GP, Hutchison DM, Nicolela MT, Burgoyne CF. Enhanced detection of open-angle glaucoma with an anatomically accurate optical coherence tomography-derived neuroretinal rim parameter. Ophthalmology. 2013 Mar;120(3):535-543. doi: 10.1016/j.ophtha.2012.09.055. Epub 2012 Dec 23.

    PubMed 23265804

  • Bussel II, Wollstein G, Schuman JS. OCT for glaucoma diagnosis, screening and detection of glaucoma progression. Br J Ophthalmol. 2014 Jul;98 Suppl 2(Suppl 2):ii15-9. doi: 10.1136/bjophthalmol-2013-304326. Epub 2013 Dec 19.

    PubMed 24357497

  • Almobarak FA, O'Leary N, Reis AS, Sharpe GP, Hutchison DM, Nicolela MT, Chauhan BC. Automated segmentation of optic nerve head structures with optical coherence tomography. Invest Ophthalmol Vis Sci. 2014 Feb 26;55(2):1161-8. doi: 10.1167/iovs.13-13310.

    PubMed 24474272

  • Wu H, de Boer JF, Chen TC. Diagnostic capability of spectral-domain optical coherence tomography for glaucoma. Am J Ophthalmol. 2012 May;153(5):815-826.e2. doi: 10.1016/j.ajo.2011.09.032. Epub 2012 Jan 20.

    PubMed 22265147

  • Wu H, de Boer JF, Chen TC. Reproducibility of retinal nerve fiber layer thickness measurements using spectral domain optical coherence tomography. J Glaucoma. 2011 Oct;20(8):470-6. doi: 10.1097/IJG.0b013e3181f3eb64.

    PubMed 20852437

Questions about this trial

What is this clinical trial studying?

A study testing SD-OCT Spectralis in people with Glaucoma and Ocular Hypertension, run by University Hospital, Bordeaux at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 26 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of Bruch's Membrane Opening Minimum Rim Width (time frame: 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02710916, which also lists 26 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.

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SD-OCT Multimodal Analysis in GLaucoma (NCT02710916) | AzTrials