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UVX as an Adjuvant in the Treatment of Fungal Keratitis

Sponsor
Farabi Eye Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03138785
Collaborator
(none)
20
Enrollment
2
Arms
30
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

In this study, investigators want to find the effect of adjuvant collagen cross-linking in the treatment of fungal keratitis

Condition or Disease Intervention/Treatment Phase
  • Drug: topical voriconazole / levofloxacin systemic itraconazole
  • Radiation: CXL
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
UVX as an Adjuvant in the Treatment of Fungal Keratitis
Actual Study Start Date :
Jan 1, 2015
Anticipated Primary Completion Date :
Jun 1, 2017
Anticipated Study Completion Date :
Jul 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: conventional treatment

In this arm, patients with documented fungal keratitis undergo conventional medical treatment.

Drug: topical voriconazole / levofloxacin systemic itraconazole
starting topical voriconazole every hour tapering after 4 days , levofloxacin every 6 hours, Itraconazole 100mg /BD for 2 weeks
Active Comparator: conventional treatment +CXL

In this arm, patients with documented fungal keratitis undergo conventional medical treatment plus CXL, beginning on the first day

Drug: topical voriconazole / levofloxacin systemic itraconazole
starting topical voriconazole every hour tapering after 4 days , levofloxacin every 6 hours, Itraconazole 100mg /BD for 2 weeks

Radiation: CXL
30 min Riboflavin prescription to the cornea followed by 30 min UV-A radiation at 3mW/cm2 associated with Riboflavin administration
Other Names:
  • Collagen cross-linking/ UVx

    		•

    Outcome Measures

    Primary Outcome Measures

    1. time of complete healing (days) [180 days]

      time to scar formation (days)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • fungal keratitis documented by culture or confocal scanning without any previous treatment
    Exclusion Criteria:

    • Previous treatment

    • Thinning at presentation

    • Perforation

    • Associated with other microbial or viral keratitis

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Farabi Eye Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    mohammad soleimani, assistant professor, Farabi Eye Hospital
    ClinicalTrials.gov Identifier:
    NCT03138785
    Other Study ID Numbers:
    • 32768
    First Posted:
    May 3, 2017
    Last Update Posted:
    May 3, 2017
    Last Verified:
    Apr 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Keratitis
    Itraconazole
    Voriconazole
    Levofloxacin
    Ofloxacin

    Study Results

    No Results Posted as of May 3, 2017