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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Shahid Beheshti Medical University
Sponsor:
Collaborator:
Shahid Beheshti Medical University
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

March 7, 2013
March 19, 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 ] [ Designated as safety issue: Yes ]
during first 3 months
Same as current
Complete list of historical versions of study NCT01814514 on ClinicalTrials.gov Archive Site
intraocular pressure success rate [ Time Frame: after 12 months ] [ Designated as safety issue: Yes ]
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
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.
 
Recruiting
94
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
Both
18 Years to 80 Years
Yes
Contact: Mohammad pakravan, Associate Professor labbafi@hotmail.com
Iran, Islamic Republic of
 
NCT01814514
90166
No
Zahra Rabbani Khah, Shaheed Beheshti Medical University
Zahra Rabbani Khah
Shahid Beheshti Medical University
Not Provided
Shahid Beheshti Medical University
March 2013

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