Traumatic Optic Neuropathy Treatment study (TONT study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Aurolab
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Number of Participants with Change/Improvement Visual Acuity From the Baseline [Time Frame: Change from baseline at least 3 months after treatment]
研究概览
简要总结
· Changein Mean number of visible colour plates in Colour vision test book. It is from21/21 to 0/21 as assessed by Ishihara 21-plate colour test book[ Time Frame: Before treatment and on day 1,2,3, 7, 30, and 90days after the treatment and through study completion, an average of 24months ]
· Numberof patients with treatment related adverse effects as assessed by historytaking (change in mood, vertigo, faint), examination (blood pressure) historytaking (change in mood, vertigo, faint), examination (blood pressure) and bloodtests (RBS, CBC, BUN, Cr., K, Hb) will be performed on baseline visit and atMonth 1 and 3; blood tests (RBS, Hb) will be performed on day 1, 2 and 3 (beforeinjection).
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •a) Having indirect traumatic optic neuropathy (with normal eye and fundus exam) b) Trauma to treatment interval of 2 weeks and less.
排除标准
- •a) Direct optic neuropathy b) Glaucoma c) Any retinopathy d) Globe laceration e) Hypertension f) Polycythaemia g) Creatinine more than 3 mg/dl, h) Patients who have received any other form of treatment for their traumatic optic neuropathy.
结局指标
主要结局
Number of Participants with Change/Improvement Visual Acuity From the Baseline [Time Frame: Change from baseline at least 3 months after treatment]
时间窗: 3 months
次要结局
- Relative Afferent Pupillary Defect, Color Vision, Side Effects(3 months)