跳至主要内容
临床试验/NCT02864134
NCT02864134已完成不适用

Predictive Effect of Ganglion Cell Layer on Visual Acuity at 6 Months and on Visual Function at 1 Year After an Episode of Optic Neuritis

CHU de Quebec-Universite Laval1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2016年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
25
试验地点
1
主要终点
Association between the analysis of ganglion cells at diagnosis and the visual function at 12 months after optic neuritis

研究概览

简要总结

BACKGROUND AND OBJECTIVES: The recent expansion of the applications of optical coherence tomography (OCT) demonstrated a higher correlation between the analysis of ganglion cells and visual function, in comparison with the analysis of the nerve fiber layer for several diseases of the optic nerve. Atrophy of the ganglion cells tends to induce the visual function deficits. In the case of optic neuritis, inflammation of the optic nerve causes a deficit of visual function initially with low vision, color blindness and visual field. Secondary atrophy of ganglion cell can result. The purpose of the study is to evaluate the correlation between the analysis of ganglion cells at the time of diagnosis of optic neuritis and the resulting visual acuity at 6 months and visual function (visual acuity, color vision and perimetry) 1 year regardless of treatment. A predictive effect could help predict the patient's clinical course and management of uncertainty and anxiety. MATERIALS AND METHODS: An assessment at diagnosis and follow-ups at 6 months and 1 year with a measurement of best corrected visual acuity, a test color vision HRR (Hardy-Rand-Rittler), an OCT with analysis of ganglion cells and perimetry Humphrey 30 -2 fast will be done. Simple linear and logistic regressions will be used. RESULTS: We expect that there will be a significant association between atrophy of ganglion cells in the diagnosis and residual visual function after an episode of optic neuritis. We believe that the initial atrophy is associated with poorer visual prognosis. CONCLUSION: A predictive effect could help to inform the patient about the evolution of the disease and provide early visual rehabilitation.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Major and apt patients seen in consultation with diagnosis of optic neuritis

排除标准

  • Concomitant ophthalmic diseases
  • known macular pathology
  • Amblyopia
  • History of an ophthalmic surgery
  • Family history of hereditary optic neuropathy
  • Pathological myopia (refractive error of 8 diopters or more).
  • Known neurological disease other than multiple sclerosis.
  • Nutritional deficiency anorexia, restrictive gastrointestinal surgery.
  • Active or former professional or recreational exposure
  • Exposure to metals: lead, mercury, thallium
  • Exposure to solvents: ethylene glycol, toluene, styrene, perchlorethylene;
  • Prior poisoning: methanol, carbon dioxide.
  • Usual or earlier Medication
  • Taking one or more drugs known to cause toxic optic neuropathy*
  • listed available on demand

结局指标

主要结局

Association between the analysis of ganglion cells at diagnosis and the visual function at 12 months after optic neuritis

时间窗: 12 months post optic neuritis

Evaluation of the visual function (best corrected visual acuity, perimetry, color vision) at 12 months post optic neuritis episode in correlation with initial ganglion cell layer analysis measures in order to predict the visual acuity in the future.

Association between the analysis of ganglion cells at diagnosis and the resulting visual acuity at 6 months after optic neuritis

时间窗: 6 months post optic neuritis

Evaluation of best corrected visual acuity at 6 months post optic neuritis episode in correlation with initial ganglion cell layer analysis measures in order to predict the visual acuity in the future.

次要结局

未报告次要终点

研究者

发起方
CHU de Quebec-Universite Laval
申办方类型
Other
责任方
Principal Investigator
主要研究者

Andréane Lavallée

Ophthalmologist

CHU de Quebec-Universite Laval

研究点 (1)

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