This double blinded, stratified, randomized clinical trial was designed to evaluate safety and efficacy of pre-treatment with Betamethasone eye drop in Ahmed Glaucoma Valve implantation
Design
A randomized, double blinded, parallel trial
Settings and conduct
All procedures were performed by unique glaucoma surgeon (M.Yadgari) in Basir eye clinic. Participants and data analyzer were blinded in this study.
Participants/Inclusion and exclusion criteria
Patients with no age limit with IOPs less than target pressure in whom Glaucoma Drainage Implant (GDI) surgery was planned were enrolled in the study. Exclusion criteria were no light perception at baseline or history of ocular surface infection in recent two weeks, pregnancy, breast feeding, lack of healthy conjunctiva for AGV insertion, and sensitivity to Betamethasone eye drop.
Intervention groups
1) Insertion of Ahmed valve in supratemporal quadrant with prescribed betamethasone eye drop 1% from 3 days before surgery until the time of surgery
2) Insertion of Ahmed valve in supratemporal quadrant with no prescription of betamethasone before surgery
Main outcome variables
Intraocular pressure (IOP); possible need to anti-glaucoma medications
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180902040928N1
Registration date:2019-01-05, 1397/10/15
Registration timing:retrospective
Last update:2019-01-05, 1397/10/15
Update count:0
Registration date
2019-01-05, 1397/10/15
Registrant information
Name
Maryam Yadgari
Name of organization / entity
Basir eye health research center
Country
Iran (Islamic Republic of)
Phone
+98 21 6694 0404
Email address
sobhanisoheila@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-09-22, 1395/07/01
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
Pretreatment with topical betamethasone in ahmed glaucoma valve implantation
Public title
Pretreatment with topical betamethasone in ahmed glaucoma valve implantation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with no age limit with IOPs less than target pressure in whom glaucoma drainage implant (GDI) surgery was planned were enrolled in the study
Exclusion criteria:
Exclusion criteria were no light perception at baseline
history of ocular surface infection in recent two weeks
pregnancy
breast feeding
lack of healthy conjunctiva for AGV insertion
sensitivity to betamethasone eye drop
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
108
Randomization (investigator's opinion)
Randomized
Randomization description
Stratified block randomization was performed. We divided eyes into 2 subgroups as follow: group 1: patients undergone previous failed antiglaucoma surgery, group 2: patients without previous antiglaucoma surgery.
In each subgroup, eyes are randomly assigned to the study arms using random blocks: totally 108 patients were enrolled dividing into 2 groups of conventional Ahmed Glaucoma Valve (AGV) implantation (group A, 54 eyes), Ahmed Glaucoma Valve (AGV) with pre-operative dropped betamethasone (group B, 54 eyes).
Blinding (investigator's opinion)
Double blinded
Blinding description
participants and data analyser were blinded in this study
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
Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2018-10-28, 1397/08/06
Ethics committee reference number
IR.IUMS.REC.1397.413
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
first day, first week, month 1, 3, 6, 9 and 12 after the surgery
Method of measurement
Goldman applanation tonometry
Secondary outcomes
1
Description
number of eyes requiring medications
Timepoint
first day, first week, month 1, 3, 6, 9 and 12 after the surgery
Method of measurement
Quantitative
2
Description
number of medications
Timepoint
first day, first week, month 1, 3, 6, 9 and 12 after the surgery
Method of measurement
Quantitative
3
Description
Best corrected visual acuity (BCVA)
Timepoint
first day, first week, month 1, 3, 6, 9 and 12 after the surgery
Method of measurement
tumbling E-chart
4
Description
Complications
Timepoint
first day, first week, month 1, 3, 6, 9 and 12 after the surgery
Method of measurement
qualitative
Intervention groups
1
Description
Intervention group: pre-treatment with betamethasone eye drop 1% from 3 days before surgery until the time of surgery, 6 times a day in patients candidate for insertion of Ahmed valve in supra temporal area of eye
Category
Treatment - Drugs
2
Description
Control group: conventional insertion of Ahmed valve in supra temporal area of eye without pre-treatment betamethasone prescription
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Basir clinic
Full name of responsible person
Maryam Yadegari
Street address
4th floor, No 3, Shahid Sheibani Alley, after Keshavarz Blvd, Jamalzadeh Shomali St
City
Tehran
Province
Tehran
Postal code
1418643113
Phone
+98 21 4424 3894
Email
info@basirclinic.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Basir eye health research center
Full name of responsible person
Maryam Yadegari
Street address
4th floor, No 3, Shahid Sheibani Alley, after Keshavarz Blvd, Jamalzadeh Shomali St
City
Tehran
Province
Tehran
Postal code
1418643561
Phone
+98 21 4424 3894
Email
info@behrc.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
No funding source is applicable
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Basir eye health research center
Full name of responsible person
Maryam Yadegari
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
4th floor, No 3, Shahid Sheibani Alley, after Keshavarz Blvd, Jamalzadeh Shomali St
City
Tehran
Province
Tehran
Postal code
1461783381
Phone
+98 21 6694 0404
Fax
Email
sobhanisoheila@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Basir eye health research center
Full name of responsible person
Maryam Yadegari
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
4th floor, No 3, Shahid Sheibani Alley, after Keshavarz Blvd, Jamalzadeh Shomali St
City
Tehran
Province
Tehran
Postal code
1461783381
Phone
+98 21 6694 0404
Fax
Email
sobhanisoheila@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Basir eye health research center
Full name of responsible person
Maryam Yadegari
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
4th floor, No 3, Shahid Sheibani Alley, after Keshavarz Blvd, Jamalzadeh Shomali St
City
Tehran
Province
Tehran
Postal code
1461783381
Phone
+98 21 6694 0404
Fax
Email
sobhanisoheila@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Results will be shown in terms of published articles