Clinical & Visual Outcomes of Collagen Cross Linking for Fungal Keratitis
Primary Purpose
Mycotic Corneal Ulcer
Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
collagen crosslinking group
Topical anti-fungal therapy
Sponsored by
About this trial
This is an interventional treatment trial for Mycotic Corneal Ulcer focused on measuring fungal keratitis, collagen cross linking
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
Sites / Locations
- Aravind Eye HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Collagen crosslinking group
standard medical therapy
Arm 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
patients were continued on topical antifungal therapy namely Natamycin eye drops and voriconazole eye drops
Outcomes
Primary Outcome Measures
size of infiltrate or scar, corneal structural integrity
Secondary Outcome Measures
visual acuity
Full Information
NCT ID
NCT02328053
First Posted
December 13, 2014
Last Updated
December 26, 2014
Sponsor
Aravind Eye Care System
1. Study Identification
Unique Protocol Identification Number
NCT02328053
Brief Title
Clinical & Visual Outcomes of Collagen Cross Linking for Fungal Keratitis
Official Title
Clinical & Visual Outcomes of Collagen Cross Linking for Fungal Keratitis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Unknown status
Study Start Date
February 2014 (undefined)
Primary Completion Date
July 2015 (Anticipated)
Study Completion Date
September 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aravind Eye Care System
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mycotic Corneal Ulcer
Keywords
fungal keratitis, collagen cross linking
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Collagen crosslinking group
Arm Type
Experimental
Arm 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
Arm Title
standard medical therapy
Arm Type
Active Comparator
Arm Description
patients were continued on topical antifungal therapy namely Natamycin eye drops and voriconazole eye drops
Intervention Type
Procedure
Intervention Name(s)
collagen crosslinking group
Other Intervention Name(s)
CXL, C3R
Intervention Description
collagen crosslinking with riboflavin and Ultraviolet A
Intervention Type
Drug
Intervention Name(s)
Topical anti-fungal therapy
Other Intervention Name(s)
natamycin, voriconazole
Intervention Description
topical antifungal medications like natamycin eye drops and voriconazole eye drops
Primary Outcome Measure Information:
Title
size of infiltrate or scar, corneal structural integrity
Time Frame
6 months
Secondary Outcome Measure Information:
Title
visual acuity
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr. Venkatesh Prajna, DNB, FRCS
Phone
+914524356100
Email
mutt@aravind.org
First Name & Middle Initial & Last Name or Official Title & Degree
Dr. Naveen R, MBBS, MS
Phone
+914524356100
Email
naveenmogana@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Venkatesh Prajna, DNB,FRCS
Organizational Affiliation
CHIEF CORNEA SERVICES
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aravind Eye Hospital
City
Madurai
State/Province
Tamilnadu
ZIP/Postal Code
624002
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Venkatesh Prajna, DNB, FRCS
Phone
+914524356100
Email
mutt@aravind.org
12. IPD Sharing Statement
Citations:
PubMed Identifier
32557558
Citation
Davis SA, Bovelle R, Han G, Kwagyan J. Corneal collagen cross-linking for bacterial infectious keratitis. Cochrane Database Syst Rev. 2020 Jun 17;6(6):CD013001. doi: 10.1002/14651858.CD013001.pub2.
Results Reference
derived
PubMed Identifier
25841317
Citation
Uddaraju M, Mascarenhas J, Das MR, Radhakrishnan N, Keenan JD, Prajna L, Prajna VN. Corneal Cross-linking as an Adjuvant Therapy in the Management of Recalcitrant Deep Stromal Fungal Keratitis: A Randomized Trial. Am J Ophthalmol. 2015 Jul;160(1):131-4.e5. doi: 10.1016/j.ajo.2015.03.024. Epub 2015 Apr 1.
Results Reference
derived
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Clinical & Visual Outcomes of Collagen Cross Linking for Fungal Keratitis
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