Can Urgent Reduction of Intraocular Pressure With Ophthalmic Timolol Improve Recovery From Non-arteritic Anterior Ischemic Optic Neuropathy (NAION): a Randomized Study.
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Number of patients with adverse events
研究概览
简要总结
The purpose of this study is to evaluate the feasibility of rapid evaluation and administration of ophthalmic Timolol maleate in the treatment of non-arteritic anterior ischemic optic neuropathy. Secondary goals are to evaluate if such treatment reduces the progression or improves recovery of patients who are randomly assigned to treatment versus standard of care.
详细描述
Non-arteritic anterior ischemic optic neuropathy (NAION) currently has no widely accepted acute treatment to improve recovery or prevent progression in the first month. It causes monocular vision loss with potential second eye involvement in 15% at 5 years. This leads to significant disability. It is the most common acute optic neuropathy in patients over 55 years of age. The final mechanism of injury is believed to be ischemic. Increasing perfusion of the optic nerve may reduce damage and prevent progression. Reduction in intraocular pressure has been shown to increase optic disc perfusion in animal models. Timolol maleate is a widely used medication for Glaucoma that reduces intraocular pressure. Treatment with Timolol maleate may improve optic disc perfusion in NAION and reduce ischemic damage from this condition. This study aims to enroll and treat patients with Timolol maleate 0.5% within 48 hours of symptom onset to assess feasibility of the study design and potential benefit of rapid intraocular pressure reduction.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 41 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sudden, painless monocular vision loss with edema of the optic disc
- •Clinical diagnosis is Non-Arteritic Anterior Ischemic Optic Neuropathy
- •Relative Afferent Pupil Defect (RAPD) at first study visit
排除标准
- •Onset of vision loss >48 hours from time of enrollment
- •History of Asthma or COPD
- •History of Heart Block or Sinus Bradycardia
- •Allergy to any beta blocker
- •History of Multiple Sclerosis or optic neuropathy
- •Active Ocular Inflammation on examination
- •Currently being treated for Cancer or systemic vasculitis
- •History of Glaucoma or use of medications that lower IOP
- •Symptomatic cataract, retinopathy, macular disease or amblyopia in the symptomatic eye
- •IOP of <10 at baseline
- •Ocular surgery in past three months
- •Women who are pregnant, breast-feeding or may become pregnant
- •Inability to provide informed consent or follow up at three months
- •Currently enrolled in any other study drug trial or previously enrolled in this study
研究组 & 干预措施
Timolol
This group will receive ophthalmic Timolol maleate 0.5%, 1 drop to the effected eye twice daily for 4 weeks.
干预措施: Timolol maleate (Drug)
结局指标
主要结局
Number of patients with adverse events
时间窗: 12 months
Recruitment Rate of patients during the one year study to assess feasibility of a larger study
时间窗: 12 months
This is to define the feasabilty of the study design for a larger study.
次要结局
- Change in the mean deviation of actual versus predicted sensitivity of the visual field.(48 hours after enrollment, 1 month, 3 months)
- Change in contrast sensitivity will be measured using the Pelli-Robson contrast sensitivity chart.(48 hours from enrollment, 1 month, 3 months.)
- Change in visual acuity at enrollment and three month follow up using a logMAR scale.(Enrolment, Within 48 hours of enrollment , 1 month, 3 months.)
- Change in Colour vision as measured by HRR colour plates.(Within 48 hours of enrollment, 1 month, 3 months)