Clinical & Visual Outcomes of Collagen Cross Linking for Fungal Keratitis

Clinical & Visual Outcomes of Collagen Cross Linking for Fungal Keratitis

Sponsors

Lead Sponsor: Aravind Eye Care System

Source 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.

Overall Status Unknown status
Start Date 2014-02-01
Completion Date 2015-09-01
Primary Completion Date 2015-07-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
size of infiltrate or scar, corneal structural integrity 6 months
Secondary Outcome
Measure Time Frame
visual acuity 6 months
Enrollment 20
Condition
Intervention

Intervention Type: Procedure

Intervention Name: collagen crosslinking group

Description: collagen crosslinking with riboflavin and Ultraviolet A

Arm Group Label: Collagen crosslinking group

Other Name: CXL, C3R

Intervention Type: Drug

Intervention Name: Topical anti-fungal therapy

Description: topical antifungal medications like natamycin eye drops and voriconazole eye drops

Other Name: natamycin, voriconazole

Eligibility

Criteria:

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

80 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Dr. Venkatesh Prajna, DNB,FRCS Principal Investigator CHIEF CORNEA SERVICES
Overall Contact

Last Name: Dr. Venkatesh Prajna, DNB, FRCS

Phone: +914524356100

Email: [email protected]

Location
Facility: Status: Contact: Aravind Eye Hospital Dr. Venkatesh Prajna, DNB, FRCS +914524356100 [email protected]
Location Countries

India

Verification Date

2014-12-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Aravind Eye Care System

Investigator Full Name: Dr.N.Venkatesh Prajna

Investigator Title: Chief Cornea Services

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Collagen crosslinking group

Type: Experimental

Description: patients not resolving to standard antifungal therapy were assigned to receive adjuvant collagen crosslinking with riboflavin and Ultraviolet-A along with topical medical therapy

Label: standard medical therapy

Type: Active Comparator

Description: patients were continued on topical antifungal therapy namely Natamycin eye drops and voriconazole eye drops

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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