Efficacy and Safety of Intraoperative Intracameral Injection Phenocaine in comparison with Preoperative Topical mydriatics in cataract surgery- Randomized control trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- 1.Pupil size
研究概览
简要总结
**Novelty of the study:**Cataract surgery is a very common surgery undertaken in Ophthalmology. Adequate pupillary mydriasis and good anesthesia is crucial for successful cataract surgery. Thus, this study is undertaken to determine the efficacy and safety of intraoperative intracameral mydriatics in comparison with preoperative topical mydriatics.
Study design: Hospital-based Randomized control study
**Objectives of the study:**To determine the efficacy and safety of intracameral mydriatic (tropicamide 0.02%+phenylephrine0.31%+lidocaine1%) in comparison with the standard preoperative mydriatics(tropicamide0.8%+phenylephrine5%).
Participants: 42 patients in each group between the age of 40 – 90 years of age undergoing cataract surgery attending Ophthalmology OPD.
Sampling/Recruitment /Collection: All uncomplicated cataract patients undergoing cataract surgery attending Ophthalmology OPD Regional Institute of Medical Sciences Hospital will be enrolled in the study.
How randomization (if any) is planned: Block randomization(block size=4)
Independent Variables (include intervention if trial): Age and sex
Outcome Variables and measurements: pupil size,postoperative day one visual acuity,corneal edema and Anterior chamber(AC) inflammation scores.
Plan of Statistical Analysis: Data collected in the proforma will be checked for consistency and completeness. Then they will be entered in the IBM SPSS version 21.0 software (IBM Corp. Armonk. NY, USA) for analysis. Descriptive statistics like mean, percentage and standard deviation will be used to represent age, sex. Pupil size will be analysed by Chi Square test .Postoperative day one visual acuity, corneal edema scores and AC inflammation scores will be compared and statistically analysed using the paired t-test and independent t-test. A p-value of <0.05 will be considered statistically significant.
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
- 40.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Uncomplicated Cataract Patients Pupil Diameter Atleast 6mm Preoperatively.
排除标准
- •Uveitis Intake of alpha blockers Use of topical or systemic NSAIDS/prostaglandins/miotics Presence of corneal opacities,pupillary deformities History of surgery in the same eye Congenital cataract and history of ocular trauma.
结局指标
主要结局
1.Pupil size
时间窗: Post Operative Day 1
2.Postoperative visual acuity
时间窗: Post Operative Day 1
3.Corneal edema
时间窗: Post Operative Day 1
4.ANTERIOR CHAMBER reaction
时间窗: Post Operative Day 1
次要结局
- not applicable(not applicable)
研究者
Dr Tharani M
Regional Institute of Medical Sciences Imphal