Effect of Fixed Brinzolamide-brimonidine Combination on Intraocular Pressure After Phacoemulsification

Cataract Clinical Trial

Official title:

Effect of Fixed Brinzolamide-brimonidine Combination on Intraocular Pressure After Phacoemulsification

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03494257
• Other study ID #: 58/15.02.2018/5104
• Status: Completed
• Phase: N/A
• First received: April 2, 2018
• Last updated: April 9, 2018
• Start date: September 4, 2017
• Est. completion date: April 6, 2018

Study information

• Verified date: April 2018
• Source: University Hospital of Patras
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: April 6, 2018
• Est. primary completion date: March 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Intraocular Pressure

Intervention

Drug:
• Brinzolamide-Brimonidine fixed combination
Simbrinza 0.2%-1% Ophthalmic Suspension

Locations

Country	Name	City	State
Greece	University Hospital of Patras	Patra	Achaia

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Patras

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IOP at 6 hours after surgery	IOP will be measured by the same Goldman applanation tonometer used preoperatively	6 hours postoperatively
Secondary	IOP at 12 hours after surgery	IOP will be measured by the same Goldman applanation tonometer used preoperatively	12 hours postoperatively
Secondary	IOP at 24 hours after surgery	IOP will be measured by the same Goldman applanation tonometer used preoperatively	12 hours postoperatively