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

NCT03642782 | Unknown

• 1 other identifier: DIOPSYS
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Conditions

Glaucoma

Keywords

electroretinogram pattern

Outcome Measures

Primary Outcomes (3)

• Correlations between Electroretinogram Pattern, vision field and optical coherence tomography

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

  Time of inclusion

• Correlations between Electroretinogram Pattern, vision field and optical coherence

  Vision field: mean deviation, corrected pattern standard deviation.

  Time of inclusion

• Correlations between Electroretinogram Pattern, vision field and optical coherence

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

  Time of inclusion

Study Arms (1)

early age of glaucoma or with important risk factors

EXPERIMENTAL

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)

Interventions

Electroretinogram Pattern (Diopsys® NOVA System) DEVICE

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

early age of glaucoma or with important risk factors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (1)

Groupe Hospitalier Paris Saint-Joseph

Paris, 75014, France

Location

Related Publications (24)

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MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2018
• First Posted: August 22, 2018
• Study Start: July 3, 2018
• Primary Completion: July 2, 2019
• Study Completion: December 31, 2023
• Last Updated: April 27, 2023

Record last verified: 2023-04

Locations

FR (1)