- Purpose: the effect of collagen cross linking on treatment bacterial corneal ulcers
- Study design: Randomized clinical trial single blind
Inclusion Patient with moderate corned ulcer who admitted in khalili eye hospital
- Exclusion criteria :
all patient with other ocular or systemic diseases like rheumatologic disorders or corneal perforation
- sample size: 32 patients
All patients received standard treatment, half of them had Collagen Cross linkage as well on the time of admission
- Time of intervention: at time of admission
- The primary outcome : Evaluation of healing of corned ulcer
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014101919581N1
Registration date:2015-01-23, 1393/11/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-01-23, 1393/11/03
Registrant information
Name
Shahram Bamdad
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3230 2830
Email address
shahrambamdad@yahoo.com
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2013-03-21, 1392/01/01
Expected recruitment end date
2013-07-23, 1392/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of UV-A/Riboflavin Collagen Cross-Linking in treatment of bacterial corneal ulcer
Public title
Evaluating the effect of UV-A/Riboflavin Collagen Cross-Linking in treatment of bacterial corneal ulcer
Purpose
Treatment
Inclusion/Exclusion criteria
32 patients with corneal ulcer will be selected 16 cases and 16 control group. The study will be restricted to patients who will refer to Khalili hospital; moderate corneal ulcers Patients that will have any kind of corneal perforation; those with a corneal descematocele;patients with collagen vascular disease and immunocompromised patients;and patients who will need any kind of emergency keratoplasty will be excluded from our study
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz Univercity of Medical Sciences
Street address
Shiraz University of Medical Science - zand blvd
City
Shiraz
Postal code
7134814336
Approval date
2014-10-16, 1393/07/24
Ethics committee reference number
CT-P-9362-6212
Health conditions studied
1
Description of health condition studied
Corneal ulcers
ICD-10 code
H16.0
ICD-10 code description
Corneal ulcer
Primary outcomes
1
Description
Corneal ulcers
Timepoint
Before the intervention, and daily
Method of measurement
Response to treatment according to improvement of ulcer with measurment of epithelialization ( milimeter ) and improvement of stromal infiltration
Secondary outcomes
1
Description
Evaluation of non- healing corneal ulcers
Timepoint
Daily
Method of measurement
No improvement in corneal epithelialization and stromal infiltrations
Intervention groups
1
Description
We do collagen cross linkage at time of addmision in case group .
We instiled Riboflavin(1%) drop every five minute till 30 minute then ultraviolet radiation ( 400nm ) for 30 minute and during this period riboflavin instiled every 5 minute.
And we start fortified cefazolin ( loomg/ml ) and fortified gentamicin ( 14 mg/ml ) every 30 minute and according to clinical response and result of culture and smear we change the therapy if needed
Category
Treatment - Surgery
2
Description
In controlled group we start fortified cefazolin ( loomg/ml ) and fortified gentamacin ( 14 mg/ml ) every 30 minute and according to clinical response and result of culture and smear we change the therapy if needed
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Khalili Hospital
Full name of responsible person
Shahram Bamdad
Street address
Khalili Street Shiraz Khalili Hospital
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz Univercity of Medical Seiences
Full name of responsible person
SAGE doctor Syed Hashmi
Street address
Shiraz Univercity of Medical Seiences- zand blvd
City
Shiraz
Grant name
دانشگاه علوم پزشکی شیراز
Grant code / Reference number
92-01-01-6212
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz Univercity of Medical Seiences
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
Shiraz Univercity of Medical Seiences
Full name of responsible person
Shahram Bamdad
Position
Corneal Fellowship
Other areas of specialty/work
Street address
Shiraz Univercity of Medical Seiences - zand blvd
City
Shiraz
Postal code
7134814336
Phone
+98 71 3230 5410
Fax
+98 71 3235 5936
Email
Shahrambamdad@yahoo.com
Web page address
Psorc.sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz Univercity of Medical Seiences-
Full name of responsible person
Shahram Bamdad
Position
Corneal Fellowship
Other areas of specialty/work
Street address
Shiraz Univercity of Medical Seiences- zand blvd
City
Shiraz
Postal code
7134814336
Phone
+98 71 3230 5410
Fax
+98 71 3235 5936
Email
Shahrambamdad@yahoo.com
Web page address
Psorc.sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz Univercity of Medical Seiences
Full name of responsible person
Shahram Bamdad
Position
Corneal Fellowship
Other areas of specialty/work
Street address
Shiraz Univercity of Medical Seiences - zand blvd
City
Shiraz
Postal code
7134814336
Phone
+98 71 3230 5410
Fax
+98 71 3235 5936
Email
Shahrambamdad@yahoo.com
Web page address
Psorc.sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)