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Evaluation of the Electroretinogram Pattern (Diopsys® NOVA System) for the Early Diagnosis of Glaucoma (DIOPSYS)

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ClinicalTrials.gov Identifier: NCT03642782
Recruitment Status : Unknown
Verified August 2018 by Groupe Hospitalier Paris Saint Joseph.
Recruitment status was:  Recruiting
First Posted : August 22, 2018
Last Update Posted : August 22, 2018
Sponsor:
Information provided by (Responsible Party):
Groupe Hospitalier Paris Saint Joseph

Brief Summary:

Glaucoma is a common and potentially blinding disease. It is characterized by an optic nerve damage, a visual field defect and elevated intraocular pressure (IOP).

The loss of retinal nerve fibers is accompanied by functional impairment in the territories corresponding to deficits of the visual field. However, this structure-function relationship is not always found initially. These discrepancies are mainly chronological: the structural damage preceding the functional impairment sometimes of several years


Condition or disease Intervention/treatment Phase
Glaucoma Device: Electroretinogram Pattern (Diopsys® NOVA System) Not Applicable

Detailed Description:

The electroretinogram pattern (ERGP) is an electrophysiological exploration technique that reflects the activity of retinal ganglion cells. It presents itself as an objective field of vision that does not require the active collaboration of the patient. It consists in recording the electrical activity of functional retinal ganglion cells following a light stimulation. Simple (30 minutes maximum), it could improve the detection of early forms of glaucoma. A significant ERGP is also thought to be correlated with peripapillary and macular CNP structural involvement of the ganglionic complex in early forms of glaucoma (MD> -6 dB).

Some results even suggest that ganglion dysfunction could be detected by the ERGP eight years on average before the occurrence of detectable alterations on the RNFL OCT. ERGP is already recognized as a routine examination for monitoring glaucomatous patients (review side in nomenclature and reimbursed by Social Security) but it could therefore be used as a diagnostic tool in very early forms of intraocular hypertonia glaucoma so to objectify signs of preperimetric functional impairment in order to establish a suitable hypotonizing treatment and to improve the prognosis of this disease.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of the Electroretinogram Pattern (Diopsys® NOVA System) for the Early Diagnosis of Glaucoma
Actual Study Start Date : July 3, 2018
Estimated Primary Completion Date : July 3, 2019
Estimated Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Experimental: early age of glaucoma or with important risk factors
All patients included will benefit from a complete ophtalmic examination including visual acuity, slit lamp biomicroscopic examination of the anterior segment, measurement of intraocular pressure by Goldmann tonometer aplanation, dynamic gonioscopy with Posner glass. They will also have a fundus examination with examination of the retina, macula and optic nerve as well as the ERGP.
Device: Electroretinogram Pattern (Diopsys® NOVA System)
it's an additional examination that extends the duration of the ophthalmological consultation by 30 minutes




Primary Outcome Measures :
  1. Correlations between Electroretinogram Pattern, vision field and optical coherence tomography [ Time Frame: Time of inclusion ]
    Electroretinogram Patterny : Magnitude, magnitude D, Magnitude D/Magnitude ratio.

  2. Correlations between Electroretinogram Pattern, vision field and optical coherence [ Time Frame: Time of inclusion ]
    Vision field: mean deviation, corrected pattern standard deviation.

  3. Correlations between Electroretinogram Pattern, vision field and optical coherence [ Time Frame: Time of inclusion ]
    Optical coherence tomography: retinal nerve fiber layer thickness and macular analysis of the ganglionic complex.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Man and woman age ≥ 18 years
  • Francophone
  • Patient with medical insurance
  • Refraction: sphere ± 5.0 D and cylinder ± 3.0 D
  • Pupillary diameter ≥ 3mm
  • Early glaucoma patients :

    • Intraocular pressure> 21 mmHg or <21mmHg under treatment
    • Thickness of pathological retinal nerve fibers with at least one affected area (OCT)
    • At least one reliable visual field (false positives, false negatives and fixation losses ≤ 25%) and no artifacts, with Corrected Pattern Standard Deviation (CPSD) pathological in the 5% and Glaucoma Hemifield Pathological test and an early attack (MD> -6dB)
  • Patient at risk for glaucoma with:

    • And / or family history of glaucoma
    • and / or intraocular pressure> 21 mmHg
    • and / or retinal nerve fibers (pathological thickness in at least one area on the OCT)
    • and / or reliable visual field (false positives, false negatives and fixation losses ≤ 25%) and without artifact, with pathological Corrected Pattern Standard Deviation (CPSD) in the 5% and Glaucoma Hemifield Pathological Test and an early onset (MD> -6 dB).

Exclusion Criteria:

  • Visual acuity below 20/30 (Snellen scale or equivalent on another visual acuity scale)
  • Unreliable visual field (false positives, loss of fixation and false negatives> 25%)
  • History of intraocular surgery (except uncomplicated cataract surgery)
  • Ocular pathology other than associated glaucoma
  • Neurological disease affecting the visual field or the optic nerve
  • History of macular laser or pan retinal photocoagulation
  • Unreliable ERGP pattern
  • Offset OCT, unreliable
  • Refusal to participate in the study
  • Patient under tutorship or curatorship
  • Patient deprived of liberty
  • Epileptic patient
  • Eczema of the eyelids or allergy to one of the components of the electrodes or skin gel allowing the cleaning of the skin before the positioning of the electrodes.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03642782


Contacts
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Contact: LACHKAR Yves, Professor + 33 1 44 12 37 95 ylachkar@hpsj.fr
Contact: GRABER Martin, MD mgraber@hpsj.fr

Locations
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France
Groupe Hospitalier Paris Saint-Joseph Recruiting
Paris, France, 75014
Contact: Hélène BEAUSSIER, PhD, PharmD    + 33 1 44 12 70 38    crc@hpsj.fr   
Sponsors and Collaborators
Groupe Hospitalier Paris Saint Joseph
Publications of Results:

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Responsible Party: Groupe Hospitalier Paris Saint Joseph
ClinicalTrials.gov Identifier: NCT03642782    
Other Study ID Numbers: DIOPSYS
First Posted: August 22, 2018    Key Record Dates
Last Update Posted: August 22, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Groupe Hospitalier Paris Saint Joseph:
electroretinogram pattern
Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Eye Diseases