Evaluation of the Electroretinogram Pattern (Diopsys® NOVA System) for the Early Diagnosis of Glaucoma
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Correlations between Electroretinogram Pattern, vision field and optical coherence tomography
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Electroretinogram Pattern (Diopsys® NOVA System) (Device)
结局指标
主要结局
Correlations between Electroretinogram Pattern, vision field and optical coherence tomography
时间窗: Time of inclusion
Electroretinogram Patterny : Magnitude, magnitude D, Magnitude D/Magnitude ratio.
Correlations between Electroretinogram Pattern, vision field and optical coherence
时间窗: Time of inclusion
Vision field: mean deviation, corrected pattern standard deviation.
次要结局
未报告次要终点