Clinical & Visual Outcomes of Collagen Cross Linking for Fungal Keratitis

Not Applicable

• Conditions: Mycotic Corneal Ulcer
• Interventions: Procedure: collagen crosslinking group; Drug: Topical anti-fungal therapy

• Registration Number: NCT02328053
• Lead Sponsor: Aravind Eye Care System

Brief 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.

Study Timeline

• Study Start: 2014-02
• Status Verified: 2014-12
• Study First Submitted: 2014-12-13
• Study First Submitted QC: 2014-12-26
• Last Update Submitted: 2014-12-26
• Study First Posted: 2014-12-31
• Last Update Posted: 2014-12-31
• Primary Completion: 2015-07
• Study Completion: 2015-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Ulcer size more than 5 mm
• Ulcer depth upto 70% of stromal depth
• Corneal thickness of 400 microns and above

Exclusion Criteria

• Corneal thickness of below 400 microns
• Ulcers involving the limbus
• Pregnant women
• Children below the age of 18 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Collagen crosslinking group	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
standard medical therapy	Topical anti-fungal therapy	patients were continued on topical antifungal therapy namely Natamycin eye drops and voriconazole eye drops
Collagen crosslinking group	Topical anti-fungal therapy	patients not resolving to standard antifungal therapy were assigned to receive adjuvant collagen crosslinking with riboflavin and Ultraviolet-A along with topical medical therapy

Primary Outcome Measures

Name	Time	Method
size of infiltrate or scar, corneal structural integrity	6 months

Secondary Outcome Measures

Name	Time	Method
visual acuity	6 months

Trial Locations

Locations (1)

Aravind Eye Hospital; 🇮🇳 Madurai, Tamilnadu, India