Effectiveness of Pilocarpine and Brimonidine to Improve Near Visual Acuity in Patients With Monofocal Intraocular Lenses
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Change in visual acuity after administration of pilocarpine and brimonidine
研究概览
简要总结
The current study aims to assess the use of pilocarpine and brimonidine to improve near visual acuity in patietns with monofocal intraocular lenses. Thirty-three subjects with be enrolled and baseline visual acuity with be measured at near and distance. This will be compared to visual acuity after drop administration over 6 hours. A quality of life questionnaire will also be evaluated.
详细描述
This research study will try to find out if pilocarpine and brimonidine can help people with intraocular lens implants read without reading glasses. Thirty-three subjects will take part in this research study. Baseline visual acuity with be measured at near and distance. This will be compared to visual acuity after drop administration over 6 hours. A quality of life questionnaire will also be evaluated.All subjects will take part at Massachusetts Eye and Ear Infirmary (MEEI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals must meet all of the inclusion criteria in order to be eligible to participate in the study. Men and women between ages 60 years and above with monofocal intraocular lenses bilaterally corrected for distance and +/- 0.5D sphere vision who need only +/- 2.5 D correction for reading. Given the age group selected only post menopausal women will be evaluated.
排除标准
- •Individuals meeting any of the exclusion criteria at baseline will be excluded from study participation including: allergies to proparacaine, pilocarpine or brimonidine, eye infection or inflammation, glaucoma, retinal tear or retinal disease, eye surgery within the past 30 days, use of eye drops within the last seven days, participated in any other research study within the past 30 days. Patients using contact lenses.
研究组 & 干预措施
Intervention
Interventions will be the drugs:
- pilocarpine - 0.5%
- brimonidine - 0.2%
One drop of each of the study drugs will be placed in the non-dominant eye and patient will be evaluated for adverse events. At hour 1 and 3 vision will be measured for distance at 20 ft and reading at 14 inches; pupil size will be measured and patient will be evaluated for adverse events. At hour 6 vision will be measured for distance at 20 ft and reading at 14 inches; pupil size will be measured; patient will be evaluated for adverse events; and quality of life/satisfaction survey (NEI RQL-42) will be given to patient.
干预措施: Brimonidine, pilocarpine (Drug)
结局指标
主要结局
Change in visual acuity after administration of pilocarpine and brimonidine
时间窗: baseline; hour 1
The primary aim of our study is to determine if the combination of pilocarpine and brimonidine improves near visual acuity in pseudophakic subjects 1 hour following drop placement, compared to baseline.
次要结局
- Change in near and distance visual acuity(baseline; hours 1; 3; and 6)