Clinical & Visual Outcomes of Collagen Cross Linking for Fungal Keratitis

Mycotic Corneal Ulcer Clinical Trial

Official title:

Clinical & Visual Outcomes of Collagen Cross Linking for Fungal Keratitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02328053
• Other study ID #: IRB2013019CLI
• Status: Recruiting
• Phase: N/A
• First received: December 13, 2014
• Last updated: December 26, 2014
• Start date: February 2014
• Est. completion date: September 2015

Study information

• Verified date: December 2014
• Source: Aravind Eye Care System
• Contact: Dr. Venkatesh Prajna, DNB, FRCS
• Phone: +914524356100
• Email: mutt[@]aravind.org
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Corneal Ulcer
• Keratitis
• Mycotic Corneal Ulcer

Intervention

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

Locations

Country	Name	City	State
India	Aravind Eye Hospital	Madurai	Tamilnadu

Sponsors (1)

Lead Sponsor	Collaborator
Aravind Eye Care System

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	size of infiltrate or scar, corneal structural integrity		6 months	No
Secondary	visual acuity		6 months	Yes