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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03494257
Other study ID # 58/15.02.2018/5104
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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