This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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
Shahid Beheshti University of Medical Sciences
Information provided by (Responsible Party):
Zahra Rabbani Khah, Shaheed Beheshti Medical University Identifier:
First received: March 7, 2013
Last updated: March 19, 2013
Last verified: March 2013

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


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01814514

Contact: Mohammad pakravan, Associate Professor

Iran, Islamic Republic of
Labbafinejad medical center Recruiting
Tehran, Iran, Islamic Republic of
Contact: Mohammad Pakravan, Associate Professor   
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 Identifier: NCT01814514     History of Changes
Other Study ID Numbers: 90166
Study First Received: March 7, 2013
Last Updated: March 19, 2013

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

Additional relevant MeSH terms:
Ocular Hypertension
Eye Diseases
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 processed this record on August 17, 2017