Ignite Creation Date:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2025-12-25 @ 4:06 PM
Study NCT ID:
NCT03494257
Status:
COMPLETED
Last Update Posted:
2018-04-11
First Post:
2018-04-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Fixed Brinzolamide-brimonidine Combination on Intraocular Pressure After Phacoemulsification
Sponsor:
University Hospital of Patras
Organization:
Study Overview
Official Title:
Effect of Fixed Brinzolamide-brimonidine Combination on Intraocular Pressure After Phacoemulsification
Status:
COMPLETED
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: