Eighty diabetic patients who are underwent vitrectomy and have no history of Eye herpes infection, Refractive surgery, Autoimmune disease and Immune deficiency will be randomized into two groups to evaluate the role of umbilical cord serum therapy on improvement of corneal epithelial defect following diabetic vitrectomy. Both groups will take the conventional medication including Chloramphenicol, Betamethasone and Cycloplegic eye drops and the case group will take further umbilical cord serum eye drop in the operated eye. The corneal epithelial defect will be measured by slit lamp after surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138903241180N15
Registration date:2010-06-14, 1389/03/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-06-14, 1389/03/24
Registrant information
Name
pooya rostami
Name of organization / entity
Opthalmic Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 2258 5952
Email address
labbafi@hotmail.com
Recruitment status
Recruitment complete
Funding source
Ophthalmic Research Center
Expected recruitment start date
2009-12-28, 1388/10/07
Expected recruitment end date
2010-02-04, 1388/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The role of umbilical cord serum therapy on improvement of corneal epithelial defect following diabetic vitrectomy
Public title
The role of umbilical cord serum therapy on corneal epithelial defect
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Diabetic patients with corneal epithelial defect following diabetic vitrectomy at labbafinejad hospital. Exclusion criteria: 1) Any history of Eye herpes infection, Refractive surgery, Autoimmune disease, Immune defficiency; 2) patients with one eye 3) use of any eye drops except Chloramphenicol, Betamethasone, Cycloplegic and contact lens for corneal epithelial defect.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ophthalmic Research Center
Street address
No 23, Pasdaran Ave, 9th Boostan, Ophthalmic Research Center
City
Tehran
Postal code
166666
Approval date
2010-03-17, 1388/12/26
Ethics committee reference number
7699ت چ
Health conditions studied
1
Description of health condition studied
corneal epithelial defect
ICD-10 code
H18.9
ICD-10 code description
Disorder of cornea, unspecified
Primary outcomes
1
Description
measurement of corneal epithelial defect
Timepoint
days 3,5,7,12
Method of measurement
slit lamp
Secondary outcomes
empty
Intervention groups
1
Description
Intervention: chloramphenicol and betamethasone eye drops every 6 hours, cycloplegic (homatropine) eye drop every 8 hours plus umbilical cord serum eye drop 20% every 4 hours
Category
Treatment - Drugs
2
Description
Control: chloramphenicol and betamethasone eye drops every 6 hours, cycloplegic (homatropine) eye drop every 8 hours
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Labbafinejad Hospital
Full name of responsible person
Dr Siamak Moradian
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ophthalmic Research Center
Full name of responsible person
Ali-asghar Aghdai
Street address
No 23,Pasdaran Ave, 9th Boostan, Ophthalmic Rsearch Center
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ophthalmic Research Center
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
Ophthalmic Rsearch Center
Full name of responsible person
Dr Amir Faramarzi
Position
Ophthalmologist
Other areas of specialty/work
Street address
No 23, Pasdaran Ave, 9 th Boostan, Ophthalmic Research Center
City
Ttehran
Postal code
166666
Phone
+98 21 2259 2200
Fax
Email
labbafi@hotmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ophthalmic Research Center, Shahid Beheshti University Medical campus
Full name of responsible person
Dr Simak Moradian
Position
Ophthalmolgist
Other areas of specialty/work
Street address
N0 23, Pasdaran Ave, 9th Boostan, Ophthalmic Research Center
City
Tehran
Postal code
1666663111
Phone
+98 21 2276 6106
Fax
Email
labbafi@hotmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ophthalmic Research Center, Shahid Beheshti University Medical Campus
Full name of responsible person
Pooya Rostami
Position
General physician
Other areas of specialty/work
Street address
No 23, Pasdaran Ave, 9th Boostan, Ophthalmic Research Center
City
Tehran
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)