Effects of ethambutol on the ocular structure and function of patients receiving anti – tuberculous treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Visual fields
研究概览
简要总结
the patients will get done an arrayof non-invasive investigations on initiation of anti-tuberculosis treatment and on followups, to detect changes in their ocular structure and function, which we canreasonably anticipate keeping the increased dose and extended regimen of anti-tuberculous treatment.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Newly diagnosed patients of Tuberculosis (Clinically or Microbiologically proven/ Sputum smear positive) from the age of 18 years and above – receiving daily regimen of ATT (2HRZE+4HRE regimen).
排除标准
- •Category II, III, IV Tuberculosis patients Moderate-to-severe Glaucoma Hereditary Optic Neuropathy Ischemic Optic Neuropathy Traumatic Optic Neuropathy HIV patients on Anti-Retroviral therapy Ocular TB Tubercular meningitis Any systemic medical condition (e.g., cognitive impairment, Parkinson’s disease, Alzheimer’s disease, Multiple sclerosis and any other neurological or musculoskeletal disease) which might preclude the patient from giving reliable results on investigations.
结局指标
主要结局
Visual fields
时间窗: first visit at the start of TB treatment | second visit at 2 months | third visit at 4 months
VEP
时间窗: first visit at the start of TB treatment | second visit at 2 months | third visit at 4 months
OCT RNFL
时间窗: first visit at the start of TB treatment | second visit at 2 months | third visit at 4 months
OCT MACULA
时间窗: first visit at the start of TB treatment | second visit at 2 months | third visit at 4 months
Visual acuity
时间窗: first visit at the start of TB treatment | second visit at 2 months | third visit at 4 months
Best corrected visual acuity
时间窗: first visit at the start of TB treatment | second visit at 2 months | third visit at 4 months
Colour vision
时间窗: first visit at the start of TB treatment | second visit at 2 months | third visit at 4 months
Contrast sensitivity
时间窗: first visit at the start of TB treatment | second visit at 2 months | third visit at 4 months
次要结局
- Deterioration in ocular function or structure in terms of colour vision(contrast sensitivity)