Trial record 1 of 352 for:    "keratitis-ichthyosis-deafness syndrome" OR "Keratitis"
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Collagen Cross-linking in Infectious Keratitis Trial

This study is currently recruiting participants. (see Contacts and Locations)
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
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, see Learn About Clinical Studies.

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 September 18, 2014