Evaluation of the Electroretinogram Pattern (Diopsys® NOVA System) for the Early Diagnosis of Glaucoma (DIOPSYS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
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|
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 (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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 ]Vision field: mean deviation, corrected pattern standard deviation.
- 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.
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
|Contact: LACHKAR Yves, Professor||+ 33 1 44 12 37 email@example.com|
|Contact: GRABER Martin, MDfirstname.lastname@example.org|
|Groupe Hospitalier Paris Saint-Joseph||Recruiting|
|Paris, France, 75014|
|Contact: Hélène BEAUSSIER, PhD, PharmD + 33 1 44 12 70 38 email@example.com|