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Collagen Cross-linking in Infectious Keratitis Trial

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01831206
First Posted: April 15, 2013
Last Update Posted: May 4, 2015
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.
Information provided by (Responsible Party):
Ngamjit Kasetsuwan, Chulalongkorn University
  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
Intervention Model: Parallel Assignment
Masking: Single (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 Ngamjit Kasetsuwan, Chulalongkorn University:

Primary Outcome Measures:
  • decrement of infiltration size [ Time Frame: 1 months ]
    decrement of infiltration size between day0 and day 30


Secondary Outcome Measures:
  • number of participants with adverse events [ Time Frame: 1 months ]
    adverse events after corneal collagen cross-linking (report in descriptive study)


Enrollment: 30
Study Start Date: March 2013
Study Completion Date: December 2014
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

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
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): NCT01831206


Locations
Thailand
Ophthalmology department, King Chulalongkorn Memorial hospital
Pratumwan, Bangkok, Thailand, 10330
Sponsors and Collaborators
Chulalongkorn University
  More Information

Responsible Party: Ngamjit Kasetsuwan, Associated professor, Chulalongkorn University
ClinicalTrials.gov Identifier: NCT01831206     History of Changes
Other Study ID Numbers: 438/55
First Submitted: April 6, 2013
First Posted: April 15, 2013
Last Update Posted: May 4, 2015
Last Verified: April 2013

Keywords provided by Ngamjit Kasetsuwan, Chulalongkorn University:
corneal ulcer
keratitis

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