Evaluation of the Electroretinogram Pattern (Diopsys® NOVA System) for the Early Diagnosis of Glaucoma
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Glaucoma
- Sponsor
- Fondation Hôpital Saint-Joseph
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Correlations between Electroretinogram Pattern, vision field and optical coherence tomography
- Status
- Active, not recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
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:
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
Outcomes
Primary Outcomes
Correlations between Electroretinogram Pattern, vision field and optical coherence tomography
Time Frame: Time of inclusion
Electroretinogram Patterny : Magnitude, magnitude D, Magnitude D/Magnitude ratio.
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.