Cataract, Intraocular Pressure
Conditions
Keywords
phacoemulsification, intraocular pressure, cataract, brinzolamide, brimonidinde, fixed combination
Brief summary
This study aims to evaluate the effect of fixed brinzolamide-brimonidine combination on intaocular pressure after uncomplicated phacoemulsification surgery. Patients scheduled for phacoemulsification will be randomly assigned to 1 of 2 groups. The treatment group will receive 1 drop of brimonidine-brinzolamide fixed combination immediately after surgery, and the control group will receive no treatment. The IOP will be measured preoperatively and at 6, 12, and 24 hours postoperatively.
Detailed description
Phacoemulsification with the use of an ophthalmic viscosurgical device (OVD) and implantation of a foldable intraocular lens (IOL) is the preferred technique for cataract surgery today. OVDs in spite of their advantages in phacoemulsification surgery, have been correlated with intraocular pressure (IOP) increase within the first 24 hours postoperatively. This constitutes a frequent short-term complication of cataract surgery and can lead to corneal edema and pain. This IOP rise may also increase the risk of retinal artery occlusion, ischemic optic neuropathy, and deterioration of preexisting glaucomatous nerve damage. DuoVisc, an OVD that consists of Viscoat (chondroitin sulfate 4.0%-sodium hyaluronate 3.0%) in combination with Provisc (sodium hyaluronate 1.0%) is the most frequently used OVD during cataract surgery. To prevent IOP spikes postoperatively, various antiglaucoma agents have been used. Brinzolamide is a carbonic anhydrase inhibitor that acts upon the ciliary processes and reduces aqueous humor secretion.Brimonidine is a highly selective a2-adrenergic agonist that increases uveoscleral outflow and reduces aqueous humor production.
Interventions
Simbrinza 0.2%-1% Ophthalmic Suspension
Sponsors
University Hospital of Patras
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Patients will be unaware of their groupe assignment. The investigator who will measure the IOP will also be masked to group assignment.
Intervention model description
Prospective randomized double-masked comparative study
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients scheduled to undergo cataract surgery by phacoemulsification.
Exclusion criteria
* previous ocular surgery * ocular hypertension * pseudoexfoliation syndrome * pigment dispersion syndrome * glaucoma * history of severe cardiovascular disease, cerebral or coronary insufficiency, depression, Raynaud's phenomenon, orthostatic hypotension or thromboangiitis obliterans * hypersensitivity to sulfonamides or brimonidine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IOP at 6 hours after surgery | 6 hours postoperatively | IOP will be measured by the same Goldman applanation tonometer used preoperatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IOP at 12 hours after surgery | 12 hours postoperatively | IOP will be measured by the same Goldman applanation tonometer used preoperatively |
| IOP at 24 hours after surgery | 12 hours postoperatively | IOP will be measured by the same Goldman applanation tonometer used preoperatively |
Countries
Greece
Outcome results
None listed