Clinical & Visual Outcomes of Collagen Cross Linking for Fungal Keratitis
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
December 13, 2014
CompletedFirst Posted
Study publicly available on registry
December 31, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedDecember 31, 2014
December 1, 2014
1.4 years
December 13, 2014
December 26, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
size of infiltrate or scar, corneal structural integrity
6 months
Secondary Outcomes (1)
visual acuity
6 months
Study Arms (2)
Collagen crosslinking group
EXPERIMENTALpatients 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
ACTIVE COMPARATORpatients were continued on topical antifungal therapy namely Natamycin eye drops and voriconazole eye drops
Interventions
collagen crosslinking with riboflavin and Ultraviolet A
topical antifungal medications like natamycin eye drops and voriconazole eye drops
Eligibility Criteria
You may qualify if:
- Ulcer size more than 5 mm
- Ulcer depth upto 70% of stromal depth
- Corneal thickness of 400 microns and above
You may not qualify if:
- Corneal thickness of below 400 microns
- Ulcers involving the limbus
- Pregnant women
- Children below the age of 18 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Aravind Eye Hospital
Madurai, Tamil Nadu, 624002, India
Related Publications (2)
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.
PMID: 32557558DERIVEDUddaraju 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.
PMID: 25841317DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dr. Venkatesh Prajna, DNB,FRCS
CHIEF CORNEA SERVICES
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief Cornea Services
Study Record Dates
First Submitted
December 13, 2014
First Posted
December 31, 2014
Study Start
February 1, 2014
Primary Completion
July 1, 2015
Study Completion
September 1, 2015
Last Updated
December 31, 2014
Record last verified: 2014-12