Collagen Cross-linking in Infectious Keratitis Trial

Phase 2

Completed

• Conditions: Fungal Keratitis; Infectious Keratitis; Bacterial Keratitis
• Interventions: Procedure: Collagen cross-linking

• Registration Number: NCT01831206
• Lead Sponsor: Chulalongkorn University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Status Verified: 2013-04
• Study First Submitted: 2013-04-06
• Study First Submitted QC: 2013-04-10
• Study First Posted: 2013-04-15
• Primary Completion: 2014-03
• Study Completion: 2014-12
• Last Update Submitted: 2015-05-01
• Last Update Posted: 2015-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Collagen cross-linking	Collagen cross-linking	Collagen cross-linking with standard treatment

Primary Outcome Measures

Name	Time	Method
decrement of infiltration size	1 months	decrement of infiltration size between day0 and day 30

Secondary Outcome Measures

Name	Time	Method
number of participants with adverse events	1 months	adverse events after corneal collagen cross-linking (report in descriptive study)

Trial Locations

Locations (1)

Ophthalmology department, King Chulalongkorn Memorial hospital; 🇹🇭 Pratumwan, Bangkok, Thailand