Trial record 1 of 368 for:    "keratitis-ichthyosis-deafness syndrome" OR "Keratitis"
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Collagen Cross-linking in Infectious Keratitis Trial

This study is currently recruiting participants.
Verified April 2013 by Chulalongkorn University
Sponsor:
Information provided by (Responsible Party):
Ngamjit Kasetsuwan, Chulalongkorn University
ClinicalTrials.gov Identifier:
NCT01831206
First received: April 6, 2013
Last updated: April 10, 2013
Last verified: April 2013
  Purpose

The purpose of this study is to evaluate the efficacy of collagen cross-linking for treatment of infectious keratitis.


Condition Intervention Phase
Infectious Keratitis
Bacterial Keratitis
Fungal Keratitis
Procedure: Collagen cross-linking
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Collagen Cross-linking in Infectious Keratitis Trial

Resource links provided by NLM:


Further study details as provided by Chulalongkorn University:

Primary Outcome Measures:
  • decrement of infiltration size [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    decrement of infiltration size between day0 and day 30


Secondary Outcome Measures:
  • number of participants with adverse events [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    adverse events after corneal collagen cross-linking (report in descriptive study)


Estimated Enrollment: 30
Study Start Date: March 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Collagen cross-linking
Collagen cross-linking with standard treatment
Procedure: Collagen cross-linking

Collagen cross-linking arm will receive standard medication for corneal ulcer treatment and corneal collagen cross-linking.

Standard treatment arm will receive only standard medication.

No Intervention: standard treatment
Standard treatment alone

  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Evidence of corneal ulcer grade II or III (bacteria or fungal, or presumed bacterial or fungal)
  • Age more than 6 year
  • Patients can understand and can follow the study protocol

Exclusion Criteria:

  • Pregnancy by history or urine test
  • Evidence of herpetic keratitis
  • Evidence of corneal perforation
  • Evidence of autoimmune disease
  • Known allergy to study medication
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01831206

Contacts
Contact: Ngamjit Kasetsuwan, MD +6622564142 ngamjitk@gmail.com
Contact: Vannarut Satitpitakul, MD +6622564142 jaijaimail@hotmail.com

Locations
Thailand
Ophthalmology department, King Chulalongkorn Memorial hospital Recruiting
Pratumwan, Bangkok, Thailand, 10330
Contact: Ngamjit Kasetsuwan, MD    +6622564142    ngamjitk@gmail.com   
Principal Investigator: Ngamjit Kasetsuwan, MD         
Sponsors and Collaborators
Chulalongkorn University
  More Information

No publications provided

Responsible Party: Ngamjit Kasetsuwan, Associated professor, Chulalongkorn University
ClinicalTrials.gov Identifier: NCT01831206     History of Changes
Other Study ID Numbers: 438/55
Study First Received: April 6, 2013
Last Updated: April 10, 2013
Health Authority: Thailand: Research Institute for Health Sciences

Keywords provided by Chulalongkorn University:
corneal ulcer
keratitis

Additional relevant MeSH terms:
Communicable Diseases
Infection
Keratitis
Corneal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on April 17, 2014