Comparison of adjuvant 0.02% Chlorhexidine gluconate with 1% Povidone-Iodine in the management of fungal keratitis: A randomized controlled trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- PGIMER
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Time to ulcer healing
研究概览
简要总结
Patients presenting to Advanced Eye Centre, PGIMER, Chandigarh, India, with fungal keratitis will receive either standard antifungal therapy alone or in combination with either 0.02% Chlorhexidine or 1% Povidone-Iodine.
In this study, all participants will receive standard antifungal therapy and therefore will not cause any hindrance in the appropriate management of the disease. All the patients will be examined and at baseline the size of epithelial defect along with greatest linear dimension, size in an axis perpendicular to it, the size of stromal infiltrate and hypopyon, will be evaluated on slit lamp examination.
All the patients whose scraping revealed fungal elements either on KOH mount will be randomized into three groups:
Group A: Standard antifungal therapy with 1% Povidone- iodine 6 times a day (N=16) Group B: Standard antifungal therapy with 0.02% chlorhexidine 6 times a day (N=16) Group C : Standard antifungal therapy (N=16)
Patients will be assessed at baseline, day 3, 7, 14, 21, 60 and 90.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 14.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Evidence of fungal infection on smear microscopy or in vivo confocal microscopy.
排除标准
- •Ulcers warranting immediate surgical intervention Impending perforation, Perforated ulcer Mixed OR Bacterial infective keratitis Endophthalmitis Previous keratoplasty in affected eye Known allergy to study medications.
结局指标
主要结局
Time to ulcer healing
时间窗: Day 0, day 3, 7, 14, 21, 60 and 90
次要结局
- Best spectacle-corrected visual acuity(3 months)
- scar size(3 months)
- infiltrate size and depth(day 0, day 3, 7, 14, 21, 60 and 90)
- Time to re-epithelialization(Time to re-epithelialization)
- Microbiological cure rate(day 7)
- Need for therapeutic penetrating keratoplasty(day 0,3,7,14,21,60, 90)
- Morphological changes on in vivo confocal microscopy(day 0, 7, 90)
研究者
Arpita Kulshrestha
PGIMER, Chandigarh