Pharmacological Treatment of Presbyopia by Pilocarpine 1.25% Eye Drops
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- The changes of near vision after one hour following pilocarpine eye drop
研究概览
简要总结
In this clinical trial, a total of 75 presbyopic patients in the age range of 40 to 60 years old will be participated. The right eyes of 45 patients will be treated by Biocarpine® and they will be considered as the case group, their left eyes will be defined as the controls. In another case group, the right eyes of 30 patients will received Vuity® eye drops and their left eyes will be considered as controls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects with the best corrected visual acuity (BCVA) better than 0.3LogMAR
- •Patients with the symptom of blurred vision at near distance
排除标准
- •Patients with amblyopia, cataract, corneal opacity, glaucoma, intraocular surgery, eye troma, congenital pupil anomalies and those with the history of headache and allergy to the eye drop will be excluded from the study.
研究组 & 干预措施
Pilocarpine Therapy
The right eyes of 45 patients will be treated by Biocarpine® and Vuity® eye drops. They will be considered as the case group,
干预措施: Pilocarpine 1.25% Eye drop (Drug)
结局指标
主要结局
The changes of near vision after one hour following pilocarpine eye drop
时间窗: baseline to one hour after pilocarpine insillation
The near vision will be measured based on the LogMAR vision at a distance of 33cm before and one hour after instillation of 1.25% pilocarpine eye drop.
次要结局
未报告次要终点
研究者
Hamideh Sabbaghi
Assistant Professor
Shahid Beheshti University of Medical Sciences