Safety Study of Aqueous Suppression After Ahmed Glaucoma Valve (AGV) Implantation
Primary Purpose
Hypertensive Phase
Status
Unknown status
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Timolol-trusopt
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hypertensive Phase focused on measuring hypertensive, phase, success rate, AGV
Eligibility Criteria
Inclusion Criteria:
- patients with uncontrolled glaucoma requiring AGV device implantation.
Exclusion Criteria:
- History of AGV implantation
- Allergy to Anti glaucoma medication
- unable to come for follow up
- Known contraindication to beta blacker such as asthma- chronic obstructive pulmonary disease (COPD). Heart failure heart block
- Learning difficulty- mental illness or severely ill
Sites / Locations
- Labbafinejad medical centerRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Timolol-trusopt
placebo,Artificial tear
Arm Description
Dosage:One drop/12hours,duration:3 months
dosage:one drop/12 hours,duration:3 months
Outcomes
Primary Outcome Measures
intraocular pressure-hypertensive phase success rate
during first 3 months
Secondary Outcome Measures
intraocular pressure success rate
after 12 months
Full Information
NCT ID
NCT01814514
First Posted
March 7, 2013
Last Updated
March 19, 2013
Sponsor
Zahra Rabbani Khah
Collaborators
Shahid Beheshti University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01814514
Brief Title
Safety Study of Aqueous Suppression After Ahmed Glaucoma Valve (AGV) Implantation
Official Title
Early Intra Ocular- Pressure Control Using Aqueous Suppressive Agents After Ahmed Glaucoma Valve Implantation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
March 2013 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zahra Rabbani Khah
Collaborators
Shahid Beheshti University of Medical Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The AGV implant is designed to open when the IOP is between 8 mmHg and 10 mmHg, and thus maintains an IOP of 8 mmHg or higher. In the early period after glaucoma drainage device (GDD) surgery the intraocular pressure (IOP) classically goes through 2 phases. The hypotensive phase occurs immediately after surgery, lasts around 1 week. This is followed by the hypertensive period where the IOP tends to rise steadily above 21mmhg.
The hypertensive response seems to occur more commonly after Ahmed GDD surgery than nonvalved implants, It was reported to occur in 40% to 80% of cases. Although the hypertensive phase can last as long as 6 months it is usually during the first 1 to 4 weeks, when there is intense congestion of the bleb wall, that IOP is highest.
Previous study showed that when aqueous comes into contact with conjunctiva and Tenon's capsule,an inflammatory reaction occurs.Factors such as prostaglandins, eicosanoids, tissue growth factor beta (TGF β)has been shown to occur in glaucomatous aqueous. These mediators induce an inflammatory reaction, and if excessive, will result in fibrosis and poor functioning of the bleb. High pressure within the bleb also results in the secretion of TGF β by the bleb lining. It may result in inflammation of the bleb wall and subsequent fibrosis and poor bleb function. The investigators supposed that with early use of aqueous suppressant medication after AGV implantation, the concentration of inflammatory mediators decreased in subconjunctival space and may lead to better IOP control after shunt surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertensive Phase
Keywords
hypertensive, phase, success rate, AGV
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
94 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Timolol-trusopt
Arm Type
Active Comparator
Arm Description
Dosage:One drop/12hours,duration:3 months
Arm Title
placebo,Artificial tear
Arm Type
Placebo Comparator
Arm Description
dosage:one drop/12 hours,duration:3 months
Intervention Type
Drug
Intervention Name(s)
Timolol-trusopt
Other Intervention Name(s)
cosopt
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
intraocular pressure-hypertensive phase success rate
Description
during first 3 months
Time Frame
during first 3 months
Secondary Outcome Measure Information:
Title
intraocular pressure success rate
Description
after 12 months
Time Frame
after 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
patients with uncontrolled glaucoma requiring AGV device implantation.
Exclusion Criteria:
History of AGV implantation
Allergy to Anti glaucoma medication
unable to come for follow up
Known contraindication to beta blacker such as asthma- chronic obstructive pulmonary disease (COPD). Heart failure heart block
Learning difficulty- mental illness or severely ill
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammad pakravan, Associate Professor
Email
labbafi@hotmail.com
Facility Information:
Facility Name
Labbafinejad medical center
City
Tehran
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammad Pakravan, Associate Professor
Email
labbafi@hotmail.com
First Name & Middle Initial & Last Name & Degree
Mohammad Pakravan, Associate Professor
12. IPD Sharing Statement
Learn more about this trial
Safety Study of Aqueous Suppression After Ahmed Glaucoma Valve (AGV) Implantation
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