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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2013 by Zahra Rabbani Khah, Shaheed Beheshti Medical University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01814514
First Posted: March 20, 2013
Last Update Posted: March 20, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Shahid Beheshti University of Medical Sciences
Information provided by (Responsible Party):
Zahra Rabbani Khah, Shaheed Beheshti Medical University
  Purpose

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.


Condition Intervention Phase
Hypertensive Phase Drug: Timolol-trusopt Drug: placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Early Intra Ocular- Pressure Control Using Aqueous Suppressive Agents After Ahmed Glaucoma Valve Implantation

Resource links provided by NLM:


Further study details as provided by Zahra Rabbani Khah, Shaheed Beheshti Medical University:

Primary Outcome Measures:
  • intraocular pressure-hypertensive phase success rate [ Time Frame: during first 3 months ]
    during first 3 months


Secondary Outcome Measures:
  • intraocular pressure success rate [ Time Frame: after 12 months ]
    after 12 months


Estimated Enrollment: 94
Study Start Date: January 2011
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Timolol-trusopt
Dosage:One drop/12hours,duration:3 months
Drug: Timolol-trusopt
Other Name: cosopt
Placebo Comparator: placebo,Artificial tear
dosage:one drop/12 hours,duration:3 months
Drug: placebo

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01814514


Contacts
Contact: Mohammad pakravan, Associate Professor labbafi@hotmail.com

Locations
Iran, Islamic Republic of
Labbafinejad medical center Recruiting
Tehran, Iran, Islamic Republic of
Contact: Mohammad Pakravan, Associate Professor       labbafi@hotmail.com   
Principal Investigator: Mohammad Pakravan, Associate Professor         
Sponsors and Collaborators
Zahra Rabbani Khah
Shahid Beheshti University of Medical Sciences
  More Information

Responsible Party: Zahra Rabbani Khah, ophthalmologist, Shaheed Beheshti Medical University
ClinicalTrials.gov Identifier: NCT01814514     History of Changes
Other Study ID Numbers: 90166
First Submitted: March 7, 2013
First Posted: March 20, 2013
Last Update Posted: March 20, 2013
Last Verified: March 2013

Keywords provided by Zahra Rabbani Khah, Shaheed Beheshti Medical University:
hypertensive
phase
success rate
AGV

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases
Timolol
Dorzolamide
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors