Purpose of the study is to evaluate the effivacy of corneal collagen crosslinking on recalcitrant infectious corneal ulcers.In this clinical trial patients with infectious corneal ulcers without appropriate response to maximal conventional topical and subconjunctival antibiotics who are hospitalized in Nikookari eye hospital whose cornea are not severly thin and do not have a history of herpetic keratitis will undergo crosslinking with UV-A and riboflavin in the operation room after removal of the epithelium and will be followe up concerning the size of epithelial defect,infiltration and hypopyon.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201105074166N3
Registration date:2011-11-12, 1390/08/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-11-12, 1390/08/21
Registrant information
Name
Rana Daei Sorkhabi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1655 1332
Email address
rana@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Research vice chancellor ofTabriz University of Medical Sciences,research budget of ophthalmology department
Expected recruitment start date
2011-08-20, 1390/05/29
Expected recruitment end date
2011-11-20, 1390/08/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Riboflavin-UV A chollagen crosslinking for treatment of recalcitrant infectious corneal ulcers
Public title
The effect of cross linking on infectious corneal ulcer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Patients with infectious corneal ulcer ;with a size of more than 3 mm;with hypopyon ;hospitalized in Nikookari eye hospital ;who have received the maximal conventional treatment including fortified topical and subconjunctival antibiotics without appropriate response.
Exclusion criteria:Patients with a history of crosslinking;significant corneal thinning and descematocele formation; cases of recurrent infection;herpetic ulcers
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences Ethics Committee
Street address
Golgasht street
City
Tabriz
Postal code
Approval date
2011-08-15, 1390/05/24
Ethics committee reference number
9034
Health conditions studied
1
Description of health condition studied
Infectious corneal ulcers
ICD-10 code
H16.0
ICD-10 code description
Keratitis,Corneal ulcer
Primary outcomes
1
Description
Epithelial defect
Timepoint
Before intervention, daily until full healing,2 months postintervention
Method of measurement
Evaluation with slit lamp with flouroscien, measurement in millimetres
2
Description
Infiltration
Timepoint
Before intervention, daily until full healing,2 months postintervention
Method of measurement
Evaluation with slit lamp , measurement in millimetres
3
Description
Hypopyon
Timepoint
Before intervention, daily until full healing,2 months postintervention
Method of measurement
Evaluation with slit lamp , measurement in millimetres
Secondary outcomes
empty
Intervention groups
1
Description
Collagen cross linking with ultraviolet irradiation and riboflavin
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Nikookari Eye Hospital
Full name of responsible person
Rana Daii Sorkhabi
Street address
Abbasi street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Vice-chancellor for research
Street address
Azadi avenue, Golgasht street
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for research, Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Nikookari eye hospital, Faculty of Medicine,Tabriz University of Medcal Sciences
Full name of responsible person
Rana Daii Sorkhabi
Position
Associated professor
Other areas of specialty/work
Street address
Abbasi street
City
Tabriz
Postal code
Phone
+98 41 1657 7330
Fax
+98 41 1657 7336
Email
rana@tbzmed.ac.ir; sorkhabi_r@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nikookari eye hospital, Faculty of Medicine,Tabriz University of Medcal Sciences
Full name of responsible person
Rana Daii Sorkhabi
Position
Associated professor
Other areas of specialty/work
Street address
Abbasi street
City
Tabriz
Postal code
Phone
+98 41 1657 7330
Fax
+98 41 1657 7336
Email
rana@tbzmed.ac.ir; sorkhabi_r@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Nikookari eye hospital, Faculty of Medicine,Tabriz University of Medcal Sciences
Full name of responsible person
Rana Daii Sorkhabi
Position
Associated professor
Other areas of specialty/work
Street address
Abbasi street
City
Tabriz
Postal code
Phone
+98 41 1657 7330
Fax
+98 41 1657 7336
Email
rana@tbzmed.ac.ir; sorkhabi_r@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)