Comparison of the post-operative regime of topical medication in uncomplicated Phacoemulsification at 2 weeks and 6 weeks
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Reduction in the post operative duration of topical medication from 6 weeks to 2 weeks.
研究概览
简要总结
This study is an interventional, single blind, randomized parallel group control trial that will be conducted in Indira Gandhi Medical College and Hospital, Shimla, H.P., India, comparing the cure rates of post-operative regime of topical medication ( Moxifloxacin 0.5% + Prednisolone1% ) at 2 weeks and 6 weeks in cataract patients undergoing uncomplicated Phacoemulsification. The study duration will be 1year (9 months of data collection and 3 months of data compilation and report writing). The primary end point will be the reduction in the post operative duration of topical medication from 6 weeks to 2 weeks. The secondary outcomes will be lesser postoperative side effects like secondary glaucoma, delayed healing and antibacterial resistance and better patient compliance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 45.00 Year(s) 至 95.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients with cataract undergoing uncomplicated surgery (Phacoemulsification).
- •Patients who give consent.
排除标准
- •1.Patients with previous corneal disease, corneal trauma, or intraocular surgery.
- •Patients who had communication problems (short of hearing, language barriers, dementia, etc.).
- •Patients with glaucoma or uveitis
- •Patients with Diabetic Retinopathy, Hypertensive Retinopathy or any other macular disease
- •Use of ocular medication during or within 30 days prior to the enrollment.
- •Use of steroid during the study or within 14 days prior to enrollment.
- •Systemic diseases that can interfere with the results of the study (e.g., rheumatoid arthritis, Sjögren’s syndrome, Behçet’s disease, systemic lupus erythematosus, scleroderma with major ocular involvement, etc.);.
结局指标
主要结局
Reduction in the post operative duration of topical medication from 6 weeks to 2 weeks.
时间窗: 2 weeks
次要结局
- 1.Lesser postoperative side effects like secondary glaucoma, delayed healing & antibacterial resistance.(2. Better patient compliance)
研究者
Dr Shambhavi Jhobta
Indira Gandhi Medical College and Hospital