Early Retinal Nerve Fiber Layer Change of Ethambutol Optic Neuropathy by Optical Coherence Tomography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Change in Retinal Nerve Fiber Layer thickness measured by optical coherence tomography
研究概览
简要总结
Ethambutol is widely used as first-line drug, but has serious side effect of optic neuropathy. As previously reported, incidence of ethambutol optic neuropathy is about 1~2%, there was considerable screening efforts and medical cost is increasing. However, there is no effective treatment of ethambutol optic neuropathy or no definite preventable measure. Moreover, multi-drug resistance tuberculosis or extensively drug resistance tuberculosis is emerging, more toxic secondary drug is used in the long-term.
It is known that retinal nerve fiber layer is increased early stage in ethambutol optic neuropathy. So we decide to evaluate the retinal nerve fiber layer thickness measured by optical coherence tomography in longitudinal manner.
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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary lung tuberculosis who has not previously treated
- •Age more than 19 years and less than 70 years old
排除标准
- •spherical equivalent more than +6.00 diopter or less than -6.00 diopter by autorefraction
- •Closed angel or intraocular pressure more than 21 mmHg
- •Best corrected visual acuity less than 0.5 with severe cataract
- •Retinal disorder include branch retinal vein occlusion, diabetic macular edema, wet-type age-related macular degeneration
- •Age less than 20 years or older than 70 years old
- •Any intraocular surgery less than 3 months
- •Intellectual problems or illiterate whom could not obtained informed consent
结局指标
主要结局
Change in Retinal Nerve Fiber Layer thickness measured by optical coherence tomography
时间窗: Early Retinal Nerve Fiber Layer change of initial before anti-tuberculosis treatment, 4 months after anti-tuberculosis treatment, 6 months after anti-tuberculosis treatmen
Retinal Nerve Fiber Layer is axon of the retinal ganglion cell. It can be measured by optical coherence tomography. It is non-invasive and good reproducibility method to measure retinal nerve fiber layer in vivo.
次要结局
未报告次要终点