To assess the effect of topical ofloxacin combination of topical ofloxacin and topical povidine iodine on conjuntival flora in preoperative cataract surgery patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Comparing the efficacy of antibiotic and combination of antibiotic and povidone iodine on reducing the conjunctival bacterial flora
研究概览
简要总结
A total of 120 eyes from 120 patients will be enrolled in this prospective randomized study
After obtaining Institutional Ethics Committee approval, patients fitting in to the inclusion criteria will be taken for the study after obtaining patient’s informed consent.
Demographic information will be gathered along with the clinical history. One single skilled ophthalmologist will do a thorough visual examination that includes:
Best corrected visual acuity as measured by the Snellen chart converted to the Log MAR chart
Slit lamp examination of the anterior segment
After pupillary dilatation with 0.8 percentage Tropicamide and 5 percentage Phenylephrine eye drops fundoscopic examination using an indirect ophthalmoscope with a 20 D lens and slit lamp biomicroscopy with a 78 D lens is performed .
The Excel software program will be used to generate random numbers that will be assigned to each patient (block randomization).
Patients will then be randomly assigned to either group 1 having 60 eyes or group 2 having 60 eyes
Group 1 receiving ofloxacin eye drops
Group 2 receiving ofloxacin and povidone iodine eye drops.
All eyes will recieve 1 drop of 0.3% topical ofloxacin for a total of 3 applications per day beginning from the day of admission to the day of surgery In addition the eyes in group 2 will recieve 1 drop of topical povidone iodine 1 time a day beginning from the day of admission(day0) to the day of surgery (day 2/3)
Conjunctival swab will be obtained from either groups on the day of admission (day 0) and on the day of surgery ( day2/3 ) by swabbing inferior conjunctival fornix
The collected material will be inoculated into thioglycolate broth and petridish with solid culture medium like blood agar , chocolate agar and macconkey agar and spread with a platinum wire in lines covering all surface of the plate. The procedure allowed to isolate colonies. The plates will then be incubated for 24-48 hours presence of bacterial growth will be checked for 2 days
Ofloxacin sensitivity of the conjunctival bacterial flora will also be assessed by plating the collected material into media with ofloxacin antibiotic disc. Area of clareance of bacterial colony around the antibiotic disc will be noted
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 50.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Preoperative patients who are scheduled to undergo cataract surgery 2.Patients who are willing to participate in the study.
排除标准
- •Patients with any signs of ocular infection / adnexal infection
- •Patients with history of use of focal/systemic antibiotics within 2 months prior to surgery.
结局指标
主要结局
Comparing the efficacy of antibiotic and combination of antibiotic and povidone iodine on reducing the conjunctival bacterial flora
时间窗: 2 days
次要结局
- 2) To assess ofloxacin sensitivity on conjunctival bacterial flora in preoperative cataract patients(1 WEEK TO 2 WEEKS)
研究者
Divya Elizabeth Varghese
Sri Ramachandra Medical College and Research Institute