Objectives:Evaluation of topical Bevacizumab in sutureless Trabeculectomy in glaucoma patients
Design :double blind, randomized, one center,
sample size:20 patients
Setting and conduct: suturless trabeculectomy witha and without topical bevacizumab
Participants including major eligibility criteria:primary open angel glaucoma patients with poor control intra ocular pressure .
Intervention:suturless trabeculectomy witha topical bevacizumab
main outcome:intra ocular pressure changes
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017041433424N1
Registration date:2017-05-27, 1396/03/06
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-05-27, 1396/03/06
Registrant information
Name
Omid Bagherzadeh
Name of organization / entity
Alzahra Eye Hospital
Country
Iran (Islamic Republic of)
Phone
+98 54 3323 3551
Email address
o.bagherzadeh@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Zahedan University of Medical Sciences
Expected recruitment start date
2017-05-31, 1396/03/10
Expected recruitment end date
2017-07-23, 1396/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of topical Bevacizumab in sutureless Trabeculectomy in glaucoma patients
Public title
Evaluation of Topical Bevacizumab in Trabeculectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: intraocular pressure (IOP)>21 mmHg despite maximum tolerated medication and poor compliance leading to POAG.
Exclusion criteria : history of ocular surgery, congenital glaucoma, ocular inflammation, angle closure glaucoma, secondrty open angle glaucoma and soft tissue disease (Marfan syndrome, collagen vascular diseases etc.)
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Blocking
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Sciences
Street address
Dr Hesabi Sq
City
Zahedan
Postal code
98167-43463
Approval date
2017-03-05, 1395/12/15
Ethics committee reference number
IR. ZAUMS. REC.1395.269
Health conditions studied
1
Description of health condition studied
Glaucoma
ICD-10 code
H40.1
ICD-10 code description
Glaucoma (primary)(residual stage):chronic simple
Primary outcomes
1
Description
Intra ocular pressure
Timepoint
before study and 1month and 6 months post operation
Method of measurement
goldman tenometer
Secondary outcomes
1
Description
visual acuity
Timepoint
before study and 1month and 6 months post operation
Method of measurement
snelen chart
Intervention groups
1
Description
Control group : Sutureless Trabeculectomy ( 10 patients)
Category
Treatment - Surgery
2
Description
Intervention group : Sutureless trabecuectomy with 1.25 mg topical bevacizumab , one time ( 10 patinets)
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
zahedan alzahra eye hospital
Full name of responsible person
Omid Bagherzadeh
Street address
Zahedan motahari st
City
zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Zahedan University of Medical Sciences
Full name of responsible person
Mohammad Reza Shahraki
Street address
Dr.Hesabi Squre
City
Zahedan
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, Zahedan University of Medical Sciences