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Clinical & Visual Outcomes of Collagen Cross Linking for Fungal Keratitis

Sponsor
Aravind Eye Care System (Other)
Overall Status
Unknown status
CT.gov ID
NCT02328053
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
19
Duration (Months)
1.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: collagen crosslinking group
  • Drug: Topical anti-fungal therapy
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Clinical & Visual Outcomes of Collagen Cross Linking for Fungal Keratitis
Study Start Date :
Feb 1, 2014
Anticipated Primary Completion Date :
Jul 1, 2015
Anticipated Study Completion Date :
Sep 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Collagen crosslinking group

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
collagen crosslinking with riboflavin and Ultraviolet A
Other Names:
  • CXL, C3R

    • Drug: Topical anti-fungal therapy
    topical antifungal medications like natamycin eye drops and voriconazole eye drops
    Other Names:
  • natamycin, voriconazole

    		•
    Active Comparator: standard medical therapy

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

    Drug: Topical anti-fungal therapy
    topical antifungal medications like natamycin eye drops and voriconazole eye drops
    Other Names:
  • natamycin, voriconazole

    		•

    Outcome Measures

    Primary Outcome Measures

    1. size of infiltrate or scar, corneal structural integrity [6 months]

    Secondary Outcome Measures

    1. visual acuity [6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Aravind Eye Hospital Madurai Tamilnadu India 624002

    Sponsors and Collaborators

    • Aravind Eye Care System

    Investigators

    • Principal Investigator: Dr. Venkatesh Prajna, DNB,FRCS, CHIEF CORNEA SERVICES

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr.N.Venkatesh Prajna, Chief Cornea Services, Aravind Eye Care System
    ClinicalTrials.gov Identifier:
    NCT02328053
    Other Study ID Numbers:
    • IRB2013019CLI
    First Posted:
    Dec 31, 2014
    Last Update Posted:
    Dec 31, 2014
    Last Verified:
    Dec 1, 2014
    Keywords provided by Dr.N.Venkatesh Prajna, Chief Cornea Services, Aravind Eye Care System
    fungal keratitis
    collagen cross linking
    Additional relevant MeSH terms:
    Corneal Ulcer
    Keratitis
    Voriconazole
    Natamycin
    Antifungal Agents
    Clotrimazole
    Miconazole

    Study Results

    No Results Posted as of Dec 31, 2014