Clinical & Visual Outcomes of Collagen Cross Linking for Fungal Keratitis

December 26, 2014 updated by: Dr.N.Venkatesh Prajna, Aravind Eye Care System
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Tamilnadu
      • Madurai, Tamilnadu, India, 624002
        • Recruiting
        • Aravind Eye Hospital
        • Contact:
          • Dr. Venkatesh Prajna, DNB, FRCS
          • Phone Number: +914524356100
          • Email: mutt@aravind.org

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
size of infiltrate or scar, corneal structural integrity
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
visual acuity
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

Aravind Eye Care System

Investigators

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

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

February 1, 2014

Primary Completion (Anticipated)

July 1, 2015

Study Completion (Anticipated)

September 1, 2015

Study Registration Dates

First Submitted

December 13, 2014

First Submitted That Met QC Criteria

December 26, 2014

First Posted (Estimate)

December 31, 2014

Study Record Updates

Last Update Posted (Estimate)

December 31, 2014

Last Update Submitted That Met QC Criteria

December 26, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB2013019CLI

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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