The purpose of this study is to obtain the effectiveness of intracameral bevacizumab on trabeculectomy results, 51 patients with primary and pseudoexfoliative open angle glaucoma which are candidate for trabeculectomy will be divided randomly in two subgroups. In one group 1.25mg bevacizumab in 0.05 ml will be injected in anterior chamber after trabeculectomy through clear cornea incision using an insulin syringe. In the second group mitomycine 0.2 mg per ml will be applied on and under the scleral flap and under the conjunctiva for 2 minutes, followed by irrigation with 200 mL physiologic saline.
At the follow up periods (1week, 1months, 3months and 6months) variables such as intraocular pressure and success rate of each method will be analyzed using proper statistical analysis.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014042617443N1
Registration date:2014-08-04, 1393/05/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-08-04, 1393/05/13
Registrant information
Name
Mostafa Mafi
Name of organization / entity
Farabi Eye Hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 6691 9709
Email address
m_mafi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research center of Tehran University of Medical sciences
Expected recruitment start date
2013-09-23, 1392/07/01
Expected recruitment end date
2014-09-23, 1393/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Intracameral Bevacizumab and Trabeculectomy Versus Trabeculectomy With Mitomycin C Alone for Open Angle Glaucoma: A clinical trial
Public title
The effect of itracameral bevacizumab injection on outcome of trabeculectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: primary openagle glaucoma candidate for trabeculectomy; pseudoexfoliative glaucoma candidate for trabeculectomy
Exclusion criteria: age<50 ; high risk patients for cardiovascular disease
Age
From 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
51
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
Research deputy of Tehran University of Medical Sciences
Street address
Keshavarz blv, Ghods street, 6th floor
City
Tehran
Postal code
Approval date
2013-12-05, 1392/09/14
Ethics committee reference number
92/د/130/2014
Health conditions studied
1
Description of health condition studied
primary open angel glaucoma
ICD-10 code
H40.1
ICD-10 code description
Primary open-angle glaucoma
Primary outcomes
1
Description
Intraocular pressure
Timepoint
before intervention,1 week, 1 month, 3 month and 6 months after intervention
Method of measurement
Goldman aplanation tonometer
Secondary outcomes
1
Description
bleb morphply
Timepoint
3 and 6 months after intervention
Method of measurement
morphild grading system
Intervention groups
1
Description
trabeculectomy adjunctive with 1.25mg per 0.05 ml intracameral bevacizumab
Category
Treatment - Surgery
2
Description
trabeculectomy adjunctive with 0.2 mg mitimycine c under conjuctival and scleral flap
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Farabi eye hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Teharn University of Medical Sciences
Full name of responsible person
Mostafa Mafi
Street address
6th floor, Teharn University of Medical Sciences, Ghods street, Keshavarz Blv,
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Teharn 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
Farabi eye hospital
Full name of responsible person
Mostafa Mafi
Position
Ophthalmology Resident
Other areas of specialty/work
Street address
Farabi Eye Hospital, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 6691 9709
Fax
Email
mostafa.mafi17@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Farabi Eye hospital
Full name of responsible person
Ghasem Fakhrai
Position
Glaucoma surgeon
Other areas of specialty/work
Street address
Farabi Eye Hospital, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 5540 0004
Fax
Email
fakhraie@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Farabi Eye Hospital
Full name of responsible person
Mostafa Mafi
Position
Ophthalmology Resident
Other areas of specialty/work
Street address
Farabi Eye Hospital
City
Tehran
Postal code
Phone
+98 21 6691 9709
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)