This is a prospective, randomized, comparitive study at Rassoul Akram Hospital, Tehran, Iran to compare the outcome of trabeculectomy with versus without intravitreal injection of bevacizumab in diabetic patients. 52 eyes from 52 diabetic patients with uncontrolled glaucoma will be enrolled. The eyes will be assigned randomly to 2 groups: the bevacizumab group will undergo trabeculectomy with adjunctive intravitreal bevacizumab and the control group will undergo trabeculectomy without intravitreal bevacizumab.The outcome measures are best-corrected visual acuity( BCVA), intraocular pressure(IOP), number of IOP lowering medications, complications, bleb morphologic features(based on the Indiana Bleb Appearance Grading Scale).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014102219206N3
Registration date:2014-11-08, 1393/08/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-11-08, 1393/08/17
Registrant information
Name
Naveed Nilforoushan
Name of organization / entity
Eye Research Center,Rasoul Akram Hospital,Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6650 9162
Email address
nilforoushan.n@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
vice chancellor of research, Iran university of Medical Sciences
Expected recruitment start date
2014-10-01, 1393/07/09
Expected recruitment end date
2016-11-30, 1395/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Trabeculectomy with versus without intravitreal bevacizumab in diabetic patients
Public title
Trabeculectomy with versus without intravitreal bevacizumab in diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: diabetic patients who are candidate for trabeculectomy(inadequately controlled glaucoma with maximally tolerated medical therapy or intolerance to antiglaucoma medications).
Exclusion criteria: being pregnant or currently breast feeding; past history of any ocular surgery other than cataract surgery in more than 6 months before trabeculectomy; ocular surface infection over the previous 2 weeks; systemic thromboembolic events; neovascular glaucoma; concurrent cataract surgery; age younger than 18 years old; diabetic retinopathy which needs lasertherapy or intravitreal injection of anti- VEGF over the previous 6 months or within 6 months after trabeculectomy.
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
52
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 Iran University of Medical Sciences
Street address
Iran,Tehran,Iran University of Medical Sciences
City
Tehran
Postal code
Approval date
2014-10-01, 1393/07/09
Ethics committee reference number
105/3168/د/93
Health conditions studied
1
Description of health condition studied
Glaucoma
ICD-10 code
H40
ICD-10 code description
Glaucoma
Primary outcomes
1
Description
Intra Ocular Pressure
Timepoint
Days1, 7, 14, 30, 60, 90 and 180 after trabeculectomy
Method of measurement
IOP measurement by Goldmann tonometry
Secondary outcomes
1
Description
rate of qualified sugical success
Timepoint
Days 1, 7, 14, 30, 60, 90 and 180 after trabeculectomy
Method of measurement
qualified success is IOP of 21mmHg or less and at least 20% reduction in the preoperative IOP with antiglaucoma medications where the number ofthem is less than that used before surgery.
2
Description
BCVA
Timepoint
Days 1, 7, 14, 30, 60, 90 and 180 after trabeculectomy
Method of measurement
The BCVA is measured by Snellen chart.
3
Description
number of antiglaucoma medications
Timepoint
Days 1, 7, 14, 30, 60, 90 and 180 after trabeculectomy
Method of measurement
number of drugs to control the IOP
4
Description
rate of complete surgical success
Timepoint
Days 1, 7, 14, 30, 60, 90 and 180 after trabeculectomy
Method of measurement
Complete surgical success is defined by IOP of 21mmHg or less and at least20 % reduction in the preoperative pressure without any antiglaucoma medications
5
Description
bleb evaluation results
Timepoint
months 1 and 6
Method of measurement
Bleb photographs are obtained at months 1 and at the last follow-up.Bleb photographs at the last follow-up are graded by a masked glaucoma specialist(N.Ni.) who compares the study photographs with standard photographs , according to the Indiana Bleb Appearance Grading Scale ,which is based on extension,height,vascularization, and leakage.
Intervention groups
1
Description
All surgeries are carried outby a single experienced surgeon(N.Ni.). For all eyes, after creating the scleral flap, MMC 0.02%(0.2mg/mL)isapplied using multiple thin sponges under the scleral flap between the sclera and Tenon capsule for 2 minutes. At the end of surgery, the conjunctiva is closed with10-0 nylonsutures. In the bevacizumab group after suturing the conjunctiva , 2.5mg (0.1mL)bevacizumab (Avastin) is injected intravitreally.
Category
Treatment - Drugs
2
Description
In the same fashion, trabeculectomy is performed in the control group, but without intravireal bevacizumab injection.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Rassoul Akram Hospital
Full name of responsible person
Acieh Eshaghi
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
vice chancellor of research,Iran University of Medical Sciences
Full name of responsible person
Mohammadi
Street address
Tehran,Iran University of Medical Sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
vice chancellor of research,Iran 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
Eye Research Center,Rassoul Akram Hospital
Full name of responsible person
Acieh Eshaghi
Position
ophthalmology resident
Other areas of specialty/work
Street address
Eye Research Center,Rassoul Akram Hospital
City
Tehran
Postal code
Phone
+98 21 6650 9162
Fax
Email
acieh_eshaghi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Eye Research Center, Rassoul Akram Hospital,Iran University of Medical Sciences
Full name of responsible person
Naveed Nilforoushan
Position
glaucoma fellowship
Other areas of specialty/work
Street address
Eye Research Center, Rassoul Akram Hospital
City
Tehran
Postal code
Phone
+98 21 6650 9162
Fax
Email
naveednil@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Eye Research Center, Rassoul Akram Hospital, Iran University of Medical Sciences
Full name of responsible person
Naveed Nilforoushan
Position
glaucoma fellowship
Other areas of specialty/work
Street address
City
Postal code
Phone
+98 21 6650 9162
Fax
Email
naveednil@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)