NCT02328053

Clinical & Visual Outcomes of Collagen Cross Linking for Fungal Keratitis

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Aravind Eye Care System · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Mycotic Corneal Ulcer

Interventions

Type	Name	Description
PROCEDURE	collagen crosslinking group	collagen crosslinking with riboflavin and Ultraviolet A
DRUG	Topical anti-fungal therapy	topical antifungal medications like natamycin eye drops and voriconazole eye drops

Timeline

• Start date: 2014-02-01
• Primary completion: 2015-07-01
• Completion: 2015-09-01
• First posted: 2014-12-31
• Last updated: 2014-12-31

Locations

1 site across 1 country: India