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Safety Study of Aqueous Suppression After Ahmed Glaucoma Valve (AGV) Implantation

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ClinicalTrials.gov Identifier: NCT01814514
Recruitment Status : Unknown
Verified March 2013 by Zahra Rabbani Khah, Shaheed Beheshti Medical University.
Recruitment status was:  Recruiting
First Posted : March 20, 2013
Last Update Posted : March 20, 2013
Shahid Beheshti University of Medical Sciences
Information provided by (Responsible Party):
Zahra Rabbani Khah, Shaheed Beheshti Medical University

March 7, 2013
March 20, 2013
March 20, 2013
January 2011
March 2013   (Final data collection date for primary outcome measure)
intraocular pressure-hypertensive phase success rate [ Time Frame: during first 3 months ]
during first 3 months
Same as current
No Changes Posted
intraocular pressure success rate [ Time Frame: after 12 months ]
after 12 months
Same as current
Not Provided
Not Provided
Safety Study of Aqueous Suppression After Ahmed Glaucoma Valve (AGV) Implantation
Early Intra Ocular- Pressure Control Using Aqueous Suppressive Agents After Ahmed Glaucoma Valve Implantation

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.

Not Provided
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Hypertensive Phase
  • Drug: Timolol-trusopt
    Other Name: cosopt
  • Drug: placebo
  • Active Comparator: Timolol-trusopt
    Dosage:One drop/12hours,duration:3 months
    Intervention: Drug: Timolol-trusopt
  • Placebo Comparator: placebo,Artificial tear
    dosage:one drop/12 hours,duration:3 months
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Unknown status
Not Provided
March 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • patients with uncontrolled glaucoma requiring AGV device implantation.

Exclusion Criteria:

  1. History of AGV implantation
  2. Allergy to Anti glaucoma medication
  3. unable to come for follow up
  4. Known contraindication to beta blacker such as asthma- chronic obstructive pulmonary disease (COPD). Heart failure heart block
  5. Learning difficulty- mental illness or severely ill
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
Not Provided
Not Provided
Zahra Rabbani Khah, Shaheed Beheshti Medical University
Zahra Rabbani Khah
Shahid Beheshti University of Medical Sciences
Not Provided
Shahid Beheshti University of Medical Sciences
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP