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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

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01814514
Enrollment
94
Registered
2013-03-20
Start date
2011-01-31
Completion date
Unknown
Last updated
2013-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertensive Phase

Keywords

hypertensive, phase, success rate, AGV

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.

Interventions

DRUGTimolol-trusopt
DRUGplacebo

Sponsors

Shahid Beheshti University of Medical Sciences
CollaboratorOTHER
Zahra Rabbani Khah
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
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

Design outcomes

Primary

MeasureTime frameDescription
intraocular pressure-hypertensive phase success rateduring first 3 monthsduring first 3 months

Secondary

MeasureTime frameDescription
intraocular pressure success rateafter 12 monthsafter 12 months

Countries

Iran

Contacts

Primary ContactMohammad pakravan, Associate Professor
labbafi@hotmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026