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

April 26, 2023 updated by: Groupe Hospitalier Paris Saint Joseph

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

12

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
      • Paris, France, 75014
        • Groupe Hospitalier Paris Saint-Joseph

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlations between Electroretinogram Pattern, vision field and optical coherence tomography
Time Frame: Time of inclusion
Electroretinogram Patterny : Magnitude, magnitude D, Magnitude D/Magnitude ratio.
Time of inclusion
Correlations between Electroretinogram Pattern, vision field and optical coherence
Time Frame: Time of inclusion
Vision field: mean deviation, corrected pattern standard deviation.
Time of inclusion
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.
Time of inclusion

Collaborators and Investigators

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

Sponsor

Groupe Hospitalier Paris Saint Joseph

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)

July 3, 2018

Primary Completion (Actual)

July 2, 2019

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

August 13, 2018

First Submitted That Met QC Criteria

August 20, 2018

First Posted (Actual)

August 22, 2018

Study Record Updates

Last Update Posted (Actual)

April 27, 2023

Last Update Submitted That Met QC Criteria

April 26, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DIOPSYS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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