Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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 Shahid Beheshti University of Medical Sciences.
Recruitment status was:  Recruiting
Sponsor:
Collaborator:
Shahid Beheshti University of Medical Sciences
Information provided by (Responsible Party):
Zahra Rabbani Khah, Shaheed Beheshti Medical University
ClinicalTrials.gov Identifier:
NCT01814514
First received: March 7, 2013
Last updated: March 19, 2013
Last verified: March 2013
  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 Blind (Subject, 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 Shahid Beheshti University of Medical Sciences:

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


Secondary Outcome Measures:
  • intraocular pressure success rate [ Time Frame: after 12 months ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: NCT01814514

Locations
Iran, Islamic Republic of
Labbafinejad medical center
Tehran, Iran, Islamic Republic of
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 
Study First Received: March 7, 2013
Last Updated: March 19, 2013
Health Authority: Iran: Ethics commitee

Keywords provided by Shahid Beheshti University of Medical Sciences:
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

ClinicalTrials.gov processed this record on December 09, 2016