Hypertensive Phase Clinical Trial
Official title:
Early Intra Ocular- Pressure Control Using Aqueous Suppressive Agents After Ahmed Glaucoma Valve Implantation
| NCT number | NCT01814514 |
| Other study ID # | 90166 |
| Secondary ID | |
| Status | Recruiting |
| Phase | Phase 2 |
| First received | March 7, 2013 |
| Last updated | March 19, 2013 |
| Start date | January 2011 |
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.
| Status | Recruiting |
| Enrollment | 94 |
| Est. completion date | |
| Est. primary completion date | March 2013 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 80 Years |
| Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Iran, Islamic Republic of | Labbafinejad medical center | Tehran |
| Lead Sponsor | Collaborator |
|---|---|
| Zahra Rabbani Khah | hahid Beheshti University of Medical Sciences |
Iran, Islamic Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | intraocular pressure-hypertensive phase success rate | during first 3 months | during first 3 months | Yes |
| Secondary | intraocular pressure success rate | after 12 months | after 12 months | Yes |