This prospective randomized clinical trial was designed to evaluate efficacy and safety of subconjunctival bevacizumab injection during Ahmed glaucoma valve surgery. The inclusion criteria were inadequately controlled glaucoma patients who were candidate for AGV insertion with at least 6 months of postoperative follow-up. The exclusion criteria were age younger than 18 years or being pregnant or currently breast feeding. Patients with corneal problem with unreliable IOP measurements or previous Ahmed valve surgery or scleral buckling were excluded from the study. Patients were selected randomly in conventional Ahmed glaucoma valve surgery (group 1) or Ahmed glaucoma valve surgery with 2.5 mg sub-conjunctival bevacizumab injection (group 2). A total number of 25 patients in group 1 and 25 patients in group 2 finally enrolled in the study. Bevacizumab was injected adjacent to Ahmed valve in study group in the end of surgery.The primary outcome measures were change in IOP and surgical success: post-operative IOP ≤ 21 mm Hg with at least 20% reduction in IOP, either with no medication (complete success) or with no more than 2 medications (qualified success). The second outcome measure was surgical complications in both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016042527595N1
Registration date:2016-08-03, 1395/05/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-08-03, 1395/05/13
Registrant information
Name
Arezoo Miraftabi
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6655 8811
Email address
miraftabi.a@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University Of Medical Sciences
Expected recruitment start date
2014-04-30, 1393/02/10
Expected recruitment end date
2015-10-02, 1394/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of subconjunctival Bevacizumab in Ahmed Glaucoma Valve Surgery”
Public title
Effects of Bevacizumab in Ahmed Glaucoma Valve Surgery”
Purpose
Treatment
Inclusion/Exclusion criteria
In this randomized clinical trial inclusion criteria are:1-age more than 18 with IOP>21 mmHg with maximal medications ;2- intolerance to medications ;3-history of previous cataract surgery or trabeculectomy with uncontrolled IOP ;4-low success of trabeculectomy due to conjunctival scar .Exclusion criteria are :1-patients with VA NLP; 2-indesirable informed consent ;3-patients who can not be present for follow up; 4-history of previous shunt surgery or CPC; 5-History of SB or Silicone in the eye ;6-Vitreous in AC which need VitX ;7-uveitis ;8- nanophthalmous; 9-struge weber or any disease with increased episcleral pressure ; 10-patients who need adjunct surgery in addition to shunt ;11 -NVG 12-pregnancy or lactating
patients will be enrolled from Radoul Akram Hospital and Central eye clinic and the procedure will be done with same techniques by Dr.Miraftabi and Nilforoushan.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
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
Iran University of Medical Sciences
Street address
Hemmat Highway
City
TEHRAN
Postal code
Approval date
2014-01-01, 1392/10/11
Ethics committee reference number
92031223317
Health conditions studied
1
Description of health condition studied
glaucoma
ICD-10 code
H40
ICD-10 code description
GLAUCOMA
Primary outcomes
1
Description
Intraocular pressure
Timepoint
Before surgery,1 day ,one week,One month,Three months,6 months and every three month after 6 months
Method of measurement
Goldman applanation tonometry
Secondary outcomes
1
Description
Number of glaucoma medications
Timepoint
Before surgery,1 day ,one week,One month,Three months,6 months and every three month after 6 months
Method of measurement
quantitative
2
Description
postoperative complications
Timepoint
Before surgery,1 day ,one week,One month,Three months,6 months and every three month after 6 months
Method of measurement
qualitative
Intervention groups
1
Description
Insertion of Ahmed valve in supra temporal area of eye and no injection of bevacizumab in the end of surgery
Category
Treatment - Drugs
2
Description
Insertion of Ahmed valve in supra temporal area of eye and injection of 2.5mg bevacizumab in subconjunctiva adjacent to Ahmed valve in the end of surgery
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul Akram Hospital
Full name of responsible person
Arezoo Miraftabi
Street address
City
TEHRAN
2
Recruitment center
Name of recruitment center
Central eye clinic
Full name of responsible person
Navid Nilforoushan MD
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University Of Medical Sciences
Full name of responsible person
Seyed Ali Javad Mousavi
Street address
Hemat highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Iran University of Medical Sciences
Full name of responsible person
Arezoo Miraftabi MD
Position
Assistant professor
Other areas of specialty/work
Street address
Rasoul Akram hospital,Niayesh street,Sattarkhan street
City
Tehran
Postal code
Phone
+98 21 6650 9162
Fax
Email
arezoomiraftabi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University Of Medical Sciences
Full name of responsible person
Arezoo Miraftabi MD
Position
Glaucoma fellowship
Other areas of specialty/work
Street address
Rassoul Akram Hospital, Niayesh street, Sattarkhan Street
City
Tehran
Postal code
Phone
+98 21 6650 9162
Fax
Email
arezoomiraftabi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mina Darghahi
Position
resident of ophthalmology
Other areas of specialty/work
Street address
Rasoul Akram hospital,Niayesh street, Satterkhan Street
City
Tehran
Postal code
۱۳۱۳۱-۱۴۴۵۶
Phone
+98 21 6650 9162
Fax
Email
md2513@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)