UVX as an Adjuvant in the Treatment of Fungal Keratitis

April 29, 2017 updated by: mohammad soleimani, Farabi Eye Hospital
In this study, investigators want to find the effect of adjuvant collagen cross-linking in the treatment of fungal keratitis

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time of complete healing (days)
Time Frame: 180 days
time to scar formation (days)
180 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Farabi Eye Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Anticipated)

June 1, 2017

Study Completion (Anticipated)

July 1, 2017

Study Registration Dates

First Submitted

February 22, 2017

First Submitted That Met QC Criteria

April 29, 2017

First Posted (Actual)

May 3, 2017

Study Record Updates

Last Update Posted (Actual)

May 3, 2017

Last Update Submitted That Met QC Criteria

April 29, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 32768

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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