Prospective Cross Sectional Study To Assess The Clinical Utility of Optical Coherence Tomography to Measure Axonal Degeneration of the Optic Nerve, in a Cohort of 200 Subjects Meeting the Diagnostics Criteria of Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Retinal Nerve Fiber Layer measurement (RNFL: peri-papillary OCT)
研究概览
简要总结
The purpose of this study is to collect preliminary data on retinal nerve fiber layer and ganglion cell layer damage in multiple sclerosis (MS) patients, using optical coherence tomography (OCT). For this study the Zeiss Cirrus OCT Imaging System will be used. The same system will be used consistently for the duration of the study.
详细描述
Hypothesis: Multiple sclerosis results in axonal degeneration which can be assessed objectively and non-invasively by serial OCT measurements of the RNFL and GCL.
This will be a prospective cross-sectional, non-interventional study; total recruitment will be 200 subjects. Recruitment will be stratified to enroll at least 50 subjects currently taking Lemtrada and 50 subjects with a documented diagnosis of ON. The study will enroll subjects primarily from practices in the Tampa Bay Area and adjacent counties. It is a planned non-interventional study; subjects will be followed by their neurologist and the study ophthalmologist and will receive standard of care. All subjects will have the ophthalmological examination and diagnostic measures, by the Principal Investigator, Dr. Grace Levy-Clarke, at Tampa Bay Uveitis Center.
Study Duration: The study duration will be 24 months, with an interim analysis at 50% recruitment status.
There are two primary aims of this longitudinal observational study:
- To determine whether atrophy within specific retinal layers over time is associated with clinical neurological progression of MS
- To determine whether an ON history affects the relationship described in aim # 1
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- 否
入选标准
- •Age 18 or older
- •Pregnant women will be excluded by self declaration
- •Male or female
- •A diagnosis of MS, that meets the 2010 Revised McDonald Diagnostic Criteria
- •A visual acuity of 20/400 or better in at least one eye
排除标准
- •Any ocular disease than prevents assessment of the optic nerve and macula by OCT
- •Advance glaucoma with optic nerve damage
- •Any optic neuropathy not diagnosed as ON associated with MS
- •A diagnosis of Macular Degeneration
- •Any previous ocular trauma
- •Any medical history of a cerebrovascular accident
- •Any planned ocular or systemic elective surgery during study duration
- •Any contraindication to a comprehensive dilated ophthalmic examination
- •Inability to give informed consent
结局指标
主要结局
Retinal Nerve Fiber Layer measurement (RNFL: peri-papillary OCT)
时间窗: Assessed at Baseline then 6, 12, 18 and 24-month time points
Optical Coherence Tomography (OCT) will be used to assess change in RNFL of patients with multiple sclerosis
次要结局
- Ganglion Cell Layer measurement (GCL: Macular OCT)(Assessed at Baseline then 6, 12, 18 and 24 - month time points)