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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03494257
Recruitment Status : Completed
First Posted : April 11, 2018
Last Update Posted : April 11, 2018
Sponsor:
Information provided by (Responsible Party):
Constantinos D. Georgakopoulos, MD, PhD, University Hospital of Patras

Tracking Information
First Submitted Date  ICMJE April 2, 2018
First Posted Date  ICMJE April 11, 2018
Last Update Posted Date April 11, 2018
Actual Study Start Date  ICMJE September 4, 2017
Actual Primary Completion Date March 20, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 9, 2018)
IOP at 6 hours after surgery [ Time Frame: 6 hours postoperatively ]
IOP will be measured by the same Goldman applanation tonometer used preoperatively
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 9, 2018)
  • IOP at 12 hours after surgery [ Time Frame: 12 hours postoperatively ]
    IOP will be measured by the same Goldman applanation tonometer used preoperatively
  • IOP at 24 hours after surgery [ Time Frame: 12 hours postoperatively ]
    IOP will be measured by the same Goldman applanation tonometer used preoperatively
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Fixed Brinzolamide-brimonidine Combination on Intraocular Pressure After Phacoemulsification
Official Title  ICMJE Effect of Fixed Brinzolamide-brimonidine Combination on Intraocular Pressure After Phacoemulsification
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Prospective 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
Condition  ICMJE
  • Cataract
  • Intraocular Pressure
Intervention  ICMJE Drug: Brinzolamide-Brimonidine fixed combination
Simbrinza 0.2%-1% Ophthalmic Suspension
Other Name: Simbrinza, 0.2%-1% Ophthalmic Suspension
Study Arms  ICMJE
  • Active Comparator: Brinzolamide-Brimonidine fixed combination
    1 drop of the brinzolamide-brimonidine fixed combination instilled in the patients cul de sac immediately after surgery
    Intervention: Drug: Brinzolamide-Brimonidine fixed combination
  • No Intervention: No topical IOP reducing medication
    No IOP reducing drops instilled after surgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 9, 2018)
62
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 6, 2018
Actual Primary Completion Date March 20, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Greece
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03494257
Other Study ID Numbers  ICMJE 58/15.02.2018/5104
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Constantinos D. Georgakopoulos, MD, PhD, University Hospital of Patras
Study Sponsor  ICMJE University Hospital of Patras
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Constantine Georgakopoulos, MD, PhD Medical School, University of Patras, Greece
PRS Account University Hospital of Patras
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP