Clinical & Visual Outcomes of Collagen Cross Linking for Fungal Keratitis
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- size of infiltrate or scar, corneal structural integrity
研究概览
简要总结
The study is a randomised control trial to assess the visual and clinical outcomes of collagen cross linking in fungal keratitis. Fungal keratitis is a major cause of corneal blindness in India and the therapeutic options available are minimal to handle the advanced complications and sequalae caused by the disease.The antimicrobial and tissue remodeling role of corneal cross linking was demonstrated by several studies earlier,we anted to specifically assess the role of corneal cross linking in non resolving fungal keratitis in prevention of perforation and enhancement of healing process.
详细描述
Patients with culture positive deep stromal fungal keratitis not responding to appropriate medical therapy for a period of two weeks were randomized to receive or not receive adjuvant CXL. The medical therapy was continued in both the groups and were followed up for 6 weeks after randomization. Healing of the ulcer was taken as successful outcome, while perforation and increase in ulcer size of more than 2 sq.mm from the baseline was considered as treatment failure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ulcer size more than 5 mm
- •Ulcer depth upto 70% of stromal depth
- •Corneal thickness of 400 microns and above
排除标准
- •Corneal thickness of below 400 microns
- •Ulcers involving the limbus
- •Pregnant women
- •Children below the age of 18 years
研究组 & 干预措施
Collagen crosslinking group
patients not resolving to standard antifungal therapy were assigned to receive adjuvant collagen crosslinking with riboflavin and Ultraviolet-A along with topical medical therapy
干预措施: collagen crosslinking group (Procedure)
Collagen crosslinking group
patients not resolving to standard antifungal therapy were assigned to receive adjuvant collagen crosslinking with riboflavin and Ultraviolet-A along with topical medical therapy
干预措施: Topical anti-fungal therapy (Drug)
standard medical therapy
patients were continued on topical antifungal therapy namely Natamycin eye drops and voriconazole eye drops
干预措施: Topical anti-fungal therapy (Drug)
结局指标
主要结局
size of infiltrate or scar, corneal structural integrity
时间窗: 6 months
次要结局
- visual acuity(6 months)
研究者
Dr.N.Venkatesh Prajna
Chief Cornea Services
Aravind Eye Care System