Visual Reconstitution Therapy After Optic Neuritis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Visual field
研究概览
简要总结
Incomplete remission after an optic neuritis attack is not uncommon. Visual reconstitution therapy is a software-based approach that has been shown to substantially improve residual visual field deficits in patients with pre- and postchiasmatic lesions.
The primary hypothesis of this randomized, controlled clinical trial is, that visual reconstitution therapy is superior to active comparator treatment in improving the visual field after optic neuritis.
详细描述
Patients with an acute optic neuritis (between 60 and 180 days before screening) or with residual visual deficits after a past optic neuritis are randomized in two treatment groups. Group A is instructed to perform software-based visual reconstitution therapy on a home PC daily and regularly for 30 minutes over a period of six month. Group B will perform a similarly, also software-based training program, developed to improve saccadic eye movements rather than visual fields. Patients are blinded to the respective treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Definite Optic Neuritis within 60-180 Days or < 12 months before Screening
- •Visus > 0.05
- •Visus < 0.7 or confirmed visual field deficit
- •Ability to give Informed Consent
排除标准
- •Systemic Treatment with Glucocorticosteroids within 30 days prior to Screening
- •Additional significant ophthalmological disease
- •Pregnancy
- •History of Epilepsy
- •Significant arterial Hypertension
结局指标
主要结局
Visual field
时间窗: 6 months
visual field perimetry and kampimetry at baseline and after 3 and 6 months
次要结局
- Quality of Life(6 months)
- structural retinal changes(6 months)
研究者
Friedemann Paul
Prof. Dr.
Charite University, Berlin, Germany