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

Primary Purpose

Glaucoma

Status

Active

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Electroretinogram Pattern (Diopsys® NOVA System)

About this trial

This is an interventional diagnostic trial for Glaucoma focused on measuring electroretinogram pattern

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Groupe Hospitalier Paris Saint-Joseph

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

early age of glaucoma or with important risk factors

Arm Description

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.

Outcomes

Primary Outcome Measures

Correlations between Electroretinogram Pattern, vision field and optical coherence tomography

Electroretinogram Patterny : Magnitude, magnitude D, Magnitude D/Magnitude ratio.

Correlations between Electroretinogram Pattern, vision field and optical coherence

Vision field: mean deviation, corrected pattern standard deviation.

Correlations between Electroretinogram Pattern, vision field and optical coherence

Optical coherence tomography: retinal nerve fiber layer thickness and macular analysis of the ganglionic complex.

Secondary Outcome Measures

Full Information

NCT ID

NCT03642782

First Posted

August 13, 2018

Last Updated

April 26, 2023

Sponsor

Fondation Hôpital Saint-Joseph

1. Study Identification

Unique Protocol Identification Number

NCT03642782

Brief Title

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

Acronym

DIOPSYS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

July 3, 2018 (Actual)

Primary Completion Date

July 2, 2019 (Actual)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fondation Hôpital Saint-Joseph

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glaucoma

Keywords

electroretinogram pattern

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

early age of glaucoma or with important risk factors

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Electroretinogram Pattern (Diopsys® NOVA System)

Intervention Description

it's an additional examination that extends the duration of the ophthalmological consultation by 30 minutes

Primary Outcome Measure Information:

Title

Correlations between Electroretinogram Pattern, vision field and optical coherence tomography

Description

Electroretinogram Patterny : Magnitude, magnitude D, Magnitude D/Magnitude ratio.

Time Frame

Time of inclusion

Title

Correlations between Electroretinogram Pattern, vision field and optical coherence

Description

Vision field: mean deviation, corrected pattern standard deviation.

Time Frame

Time of inclusion

Title

Correlations between Electroretinogram Pattern, vision field and optical coherence

Description

Optical coherence tomography: retinal nerve fiber layer thickness and macular analysis of the ganglionic complex.

Time Frame

Time of inclusion

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Facility Information:

Facility Name

Groupe Hospitalier Paris Saint-Joseph

City

Paris

ZIP/Postal Code

75014

Country

France

12. IPD Sharing Statement

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

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