Effect of intravitreal injection of Bevacizumab and subtenon injection of Triamcinolone and topical diclofenac eye drop in preventing the incidence of diabetic macular edema after phaco with intraocular lens implementing
This study is a prospective and randomized single blind clinical trial. The aim of this study is effect of intravitreal injection of Bevacizumab and subtenon injection of Triamcinolone and topical diclofenac eye drop in preventing the incidence of diabetic macular edema after phaco with intraocular lens implementing. Total of sample size is 45 patient with ages: 18-70 years old. The patients with diabetic macular edema, glaucoma, any history of eye surgery six months before the study will be excluded. Inclusion criteria is diabetic patients with cataract and without diabetic macular edema. Assessor of study do not know about type of drug and grouping patients. This study is 3 trial phase. All patients are undergoing phaco surgery with intraocular lens. The patients are randomly divided into three groups by blocked randomization. Each group is consisted of fifteen patients. The first group receives 1.25 milligram of intravitreal Bevacizumab injection at the end of the surgery. The second group receives 4 milligram of subtenon Triamcinolone injection at the end of the surgery. The third group as a control group receives topical diclofenac eye drop every 8 hours until 4 weeks after surgery. Patients basic information such as age and sex, stature, BMI will be recorded in both groups before intervention. Macular thickness and visual acuity and intraocular pressure will be recorded one and three months after surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017050833875N1
Registration date:2017-06-30, 1396/04/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-06-30, 1396/04/09
Registrant information
Name
Aram Mohamad Jafari
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3222 2922
Email address
mohamadjafari.a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor For Research Of Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2017-09-23, 1396/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of intravitreal injection of Bevacizumab and subtenon injection of Triamcinolone and topical diclofenac eye drop in preventing the incidence of diabetic macular edema after phaco with intraocular lens implementing
Public title
Effect of diclofenac eye drop and Bevacizumab and Triamcinolone in preventing part of the retina edema
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: Diabetic patients with cataract and without diabetic macular edema; Nonproliferation diabetic retinopathy. Exclusion Criteria: Glaucoma; Eye trauma; Laser therapy 12 months prior to cataract surgery; Any history of eye surgery 6 months ago.
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
45
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
Ethics Committee of Ahvaz Jundishapur University Of Medical Sciences
Street address
Ground Floor, Central Library, Ahvaz Jundishapur University of Medical Sciences, Golestan BLvd., Ahvaz
City
Ahvaz
Postal code
Approval date
2017-05-20, 1396/02/30
Ethics committee reference number
IR.AJUMS.REC.1396.139
Health conditions studied
1
Description of health condition studied
Diabetic retinopathy
ICD-10 code
H36.0
ICD-10 code description
Diabetic retinopathy
Primary outcomes
1
Description
Macular thickness
Timepoint
Before the surgery and one month and three months after surgery
Before the surgery and one month and three months after surgery
Method of measurement
Snellen chart
3
Description
Intraocular pressure
Timepoint
Before the surgery and one month and three months after surgery
Method of measurement
Goldman tonometer
Secondary outcomes
empty
Intervention groups
1
Description
Group I (intervention group): Prescription 1.25 milligram of intravitreal Bevacizumab injection at the end of the surgery.
Category
Prevention
2
Description
Group II (intervention group): Prescription 4 milligram of subtenon Triamcinolone injection at the end of the surgery.
Category
Prevention
3
Description
Group III (control group): Prescription topical diclofenac eye drop every 8 hours until 4 weeks after surgery.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Mostafa Feghhi
Street address
Khomeini Hospital, ShahidAhwazian St., Ahwaz
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor For Research Of Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Nader Saki
Street address
Vice chancellor For Research Of Ahvaz Jondishapour University of Medical Sciences, Ground Floor, Central Library, Ahvaz Jundishapur University of Medical Sciences, GolestanBLvd., Ahvaz
City
Ahvaz
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 Of Ahvaz Jundishapur 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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Aram Mohamad Jafari
Position
Resident of ophthalmology
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, GolestanBLvd., Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 3222 2922
Fax
Email
arammohamadjafary@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Mahmood Panahibazaz
Position
Eye surgery and professor cornea
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, GolestanBLvd., Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 3222 2922
Fax
Email
Panahibazaz_m@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Sanaz Nazari
Position
Nurse of Anesthesia
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)