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

• Sponsor: University Hospital of Patras (Other)
• Overall Status: Completed
• CT.gov ID: NCT03494257
• Collaborator: (none)
• Enrollment: 62
• Location: 1
• Arms: 2
• Actual Duration (Months): 7
• Patients Per Site Per Month: 8.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cataract; Intraocular Pressure	Drug: Brinzolamide-Brimonidine fixed combination	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 62 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Prospective randomized double-masked comparative studyProspective randomized double-masked comparative study
• Masking: Double (Participant, 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.
• Primary Purpose: Treatment
• Official Title: Effect of Fixed Brinzolamide-brimonidine Combination on Intraocular Pressure After Phacoemulsification
• Actual Study Start Date: Sep 4, 2017
• Actual Primary Completion Date: Mar 20, 2018
• Actual Study Completion Date: Apr 6, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Brinzolamide-Brimonidine fixed combination 1 drop of the brinzolamide-brimonidine fixed combination instilled in the patients cul de sac immediately after surgery	Drug: Brinzolamide-Brimonidine fixed combination; Simbrinza 0.2%-1% Ophthalmic Suspension; Other Names: Simbrinza, 0.2%-1% Ophthalmic Suspension
No Intervention: No topical IOP reducing medication No IOP reducing drops instilled after surgery

Outcome Measures

Primary Outcome Measures

1. IOP at 6 hours after surgery [6 hours postoperatively]

   IOP will be measured by the same Goldman applanation tonometer used preoperatively

Secondary Outcome Measures

1. IOP at 12 hours after surgery [12 hours postoperatively]

   IOP will be measured by the same Goldman applanation tonometer used preoperatively

2. IOP at 24 hours after surgery [12 hours postoperatively]

   IOP will be measured by the same Goldman applanation tonometer used preoperatively

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital of Patras	Patra	Achaia	Greece	26504

Sponsors and Collaborators

• University Hospital of Patras

Investigators

• Principal Investigator: Constantine Georgakopoulos, MD, PhD, Medical School, University of Patras, Greece

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Constantinos D. Georgakopoulos, MD, PhD, Associate Professor in Ophthalmology, University Hospital of Patras
• ClinicalTrials.gov Identifier: NCT03494257
• Other Study ID Numbers: 58/15.02.2018/5104
• First Posted: Apr 11, 2018
• Last Update Posted: Apr 11, 2018
• Last Verified: Apr 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Constantinos D. Georgakopoulos, MD, PhD, Associate Professor in Ophthalmology, University Hospital of Patras: phacoemulsification; intraocular pressure; cataract; brinzolamide; brimonidinde; fixed combination
• Additional relevant MeSH terms: Cataract; Brimonidine Tartrate; Brinzolamide

Study Results

No Results Posted as of Apr 11, 2018