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

Primary Purpose

Cataract, Intraocular Pressure

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Brinzolamide-Brimonidine fixed combination
Sponsored by
University Hospital of Patras
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring phacoemulsification, intraocular pressure, cataract, brinzolamide, brimonidinde, fixed combination

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital of Patras

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Brinzolamide-Brimonidine fixed combination

No topical IOP reducing medication

Arm Description

1 drop of the brinzolamide-brimonidine fixed combination instilled in the patients cul de sac immediately after surgery

No IOP reducing drops instilled after surgery

Outcomes

Primary Outcome Measures

IOP at 6 hours after surgery
IOP will be measured by the same Goldman applanation tonometer used preoperatively

Secondary Outcome Measures

IOP at 12 hours after surgery
IOP will be measured by the same Goldman applanation tonometer used preoperatively
IOP at 24 hours after surgery
IOP will be measured by the same Goldman applanation tonometer used preoperatively

Full Information

First Posted
April 2, 2018
Last Updated
April 9, 2018
Sponsor
University Hospital of Patras
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1. Study Identification

Unique Protocol Identification Number
NCT03494257
Brief Title
Effect of Fixed Brinzolamide-brimonidine Combination on Intraocular Pressure After Phacoemulsification
Official Title
Effect of Fixed Brinzolamide-brimonidine Combination on Intraocular Pressure After Phacoemulsification
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
September 4, 2017 (Actual)
Primary Completion Date
March 20, 2018 (Actual)
Study Completion Date
April 6, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital of Patras

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Intraocular Pressure
Keywords
phacoemulsification, intraocular pressure, cataract, brinzolamide, brimonidinde, fixed combination

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective randomized double-masked comparative study
Masking
ParticipantInvestigator
Masking Description
Patients will be unaware of their groupe assignment. The investigator who will measure the IOP will also be masked to group assignment.
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brinzolamide-Brimonidine fixed combination
Arm Type
Active Comparator
Arm Description
1 drop of the brinzolamide-brimonidine fixed combination instilled in the patients cul de sac immediately after surgery
Arm Title
No topical IOP reducing medication
Arm Type
No Intervention
Arm Description
No IOP reducing drops instilled after surgery
Intervention Type
Drug
Intervention Name(s)
Brinzolamide-Brimonidine fixed combination
Other Intervention Name(s)
Simbrinza, 0.2%-1% Ophthalmic Suspension
Intervention Description
Simbrinza 0.2%-1% Ophthalmic Suspension
Primary Outcome Measure Information:
Title
IOP at 6 hours after surgery
Description
IOP will be measured by the same Goldman applanation tonometer used preoperatively
Time Frame
6 hours postoperatively
Secondary Outcome Measure Information:
Title
IOP at 12 hours after surgery
Description
IOP will be measured by the same Goldman applanation tonometer used preoperatively
Time Frame
12 hours postoperatively
Title
IOP at 24 hours after surgery
Description
IOP will be measured by the same Goldman applanation tonometer used preoperatively
Time Frame
12 hours postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Constantine Georgakopoulos, MD, PhD
Organizational Affiliation
Medical School, University of Patras, Greece
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Patras
City
Patra
State/Province
Achaia
ZIP/Postal Code
26504
Country
Greece

12. IPD Sharing Statement

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

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