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

NCT01814514 | Unknown Phase 2

• 1 other identifier: 90166
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertensive Phase

Keywords

hypertensive; phase; success rate; AGV

Outcome Measures

Primary Outcomes (1)

• intraocular pressure-hypertensive phase success rate

  during first 3 months

  during first 3 months

Secondary Outcomes (1)

• intraocular pressure success rate

  after 12 months

Study Arms (2)

Timolol-trusopt

ACTIVE COMPARATOR

Dosage:One drop/12hours,duration:3 months

Drug: Timolol-trusopt

placebo,Artificial tear

PLACEBO COMPARATOR

dosage:one drop/12 hours,duration:3 months

Drug: placebo

Interventions

Timolol-trusopt DRUG

Also known as: cosopt

Timolol-trusopt

placebo DRUG

placebo,Artificial tear

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with uncontrolled glaucoma requiring AGV device implantation.

You may not qualify if:

• History of AGV implantation
• Allergy to Anti glaucoma medication
• unable to come for follow up
• Known contraindication to beta blacker such as asthma- chronic obstructive pulmonary disease (COPD). Heart failure heart block
• Learning difficulty- mental illness or severely ill

Sponsors & Collaborators

• Zahra Rabbani Khah: lead
• Shahid Beheshti University of Medical Sciences: collaborator

Study Sites (1)

Labbafinejad medical center

Tehran, Iran

RECRUITING

MeSH Terms

Interventions

dorzolamide-timolol combination

Central Study Contacts

Mohammad pakravan, Associate Professor

CONTACT

labbafi@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: ophthalmologist

Study Record Dates

• First Submitted: March 7, 2013
• First Posted: March 20, 2013
• Study Start: January 1, 2011
• Primary Completion: March 1, 2013
• Last Updated: March 20, 2013

Record last verified: 2013-03

Locations

IR (1)