ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical & Visual Outcomes of Collagen Cross Linking for Fungal Keratitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02328053
Recruitment Status : Unknown
Verified December 2014 by Dr.N.Venkatesh Prajna, Aravind Eye Care System.
Recruitment status was:  Recruiting
First Posted : December 31, 2014
Last Update Posted : December 31, 2014
Sponsor:
Information provided by (Responsible Party):
Dr.N.Venkatesh Prajna, Aravind Eye Care System

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
Mycotic Corneal Ulcer Procedure: collagen crosslinking group Drug: Topical anti-fungal therapy Not Applicable

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  (Clinical Trial)
Estimated 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 : February 2014
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Molds

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 Name: CXL, C3R

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




Primary Outcome Measures :
  1. size of infiltrate or scar, corneal structural integrity [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. visual acuity [ Time Frame: 6 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02328053


Contacts
Contact: Dr. Venkatesh Prajna, DNB, FRCS +914524356100 mutt@aravind.org
Contact: Dr. Naveen R, MBBS, MS +914524356100 naveenmogana@gmail.com

Locations
India
Aravind Eye Hospital Recruiting
Madurai, Tamilnadu, India, 624002
Contact: Dr. Venkatesh Prajna, DNB, FRCS    +914524356100    mutt@aravind.org   
Sponsors and Collaborators
Aravind Eye Care System
Investigators
Principal Investigator: Dr. Venkatesh Prajna, DNB,FRCS CHIEF CORNEA SERVICES

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr.N.Venkatesh Prajna, Chief Cornea Services, Aravind Eye Care System
ClinicalTrials.gov Identifier: NCT02328053     History of Changes
Other Study ID Numbers: IRB2013019CLI
First Posted: December 31, 2014    Key Record Dates
Last Update Posted: December 31, 2014
Last Verified: December 2014

Keywords provided by Dr.N.Venkatesh Prajna, Aravind Eye Care System:
fungal keratitis
collagen cross linking

Additional relevant MeSH terms:
Keratitis
Corneal Ulcer
Corneal Diseases
Eye Diseases
Eye Infections
Infection
Voriconazole
Natamycin
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors
Anti-Infective Agents, Local
Anti-Bacterial Agents