Clinical & Visual Outcomes of Collagen Cross Linking for Fungal Keratitis

Study Overview
=================
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.

Official Title
-----------------
Clinical & Visual Outcomes of Collagen Cross Linking for Fungal Keratitis

Conditions
-----------------
Mycotic Corneal Ulcer

Intervention / Treatment
-----------------
* Procedure: collagen crosslinking group
* Drug: Topical anti-fungal therapy


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Collagen crosslinking group<br>patients not resolving to standard antifungal therapy were assigned to receive adjuvant collagen crosslinking with riboflavin and Ultraviolet-A along with topical medical therapy | Procedure: collagen crosslinking group<br>* collagen crosslinking with riboflavin and Ultraviolet A<br>* Other names: CXL, C3R;Drug: Topical anti-fungal therapy<br>* topical antifungal medications like natamycin eye drops and voriconazole eye drops<br>* Other names: natamycin, voriconazole;|
| Active Comparator: standard medical therapy<br>patients were continued on topical antifungal therapy namely Natamycin eye drops and voriconazole eye drops | Drug: Topical anti-fungal therapy<br>* topical antifungal medications like natamycin eye drops and voriconazole eye drops<br>* Other names: natamycin, voriconazole;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| size of infiltrate or scar, corneal structural integrity |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual acuity |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fungal keratitis, collagen cross linking