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

NCT ID: NCT01814514

Last Updated: 2013-03-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Timolol-trusopt

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

Group Type: ACTIVE_COMPARATOR

Timolol-trusopt

Intervention Type: DRUG

placebo,Artificial tear

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

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Interventions

Timolol-trusopt

Intervention Type: DRUG

placebo

Intervention Type: DRUG

Other Intervention Names

cosopt

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role: collaborator

Zahra Rabbani Khah

OTHER

Sponsor Role: lead

Responsible Party

Zahra Rabbani Khah

ophthalmologist

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Labbafinejad medical center

Tehran, , Iran

Site Status: RECRUITING

Countries

Iran

Central Contacts

Mohammad pakravan, Associate Professor

Role: CONTACT

labbafi@hotmail.com

Facility Contacts

Mohammad Pakravan, Associate Professor

Role: primary

labbafi@hotmail.com

Other Identifiers

90166

Identifier Type: -

Identifier Source: org_study_id