The Effect of Voltaren-ophtha 0.1% Eye Drops on INR Levels (International Normalized Ratio) in Patients Taking Warfarin

May 29, 2016 updated by: Lili karmona, Wolfson Medical Center

The Effect of Voltaren-ophtha 0.1% (Diclofenac Sodium 0.1%) Eye Drops After Cataract Surgery on INR Levels (International Normalized Ratio) in Patients Taking Warfarin

A prospective study intended to examine the effect of topical Voltaren-Ophtha 0.1% eye drops after cataract surgery on INR levels (international normalized ratio) in patients taking warfarin.

Study Overview

Status

Unknown

Conditions

Blood Coagulation Disorders

Intervention / Treatment

Drug: Voltaren ophtha 0.1%

Detailed Description

Objective: To examine the effect of topical Voltaren-Ophtha 0.1% eye drops after cataract surgery on INR levels ( international normalized ratio) in patients taking warfarin.

Methods: A prospective study. The study population will include approximately 100 patients, taking warfarin and that are candidates for cataract surgery. These patients will continue their warfarin therapy as usual and at the same dose, before and after the operation.

INR levels (international normalized ratio) will be checked once a week while taking Voltaren eye drops as is customary after cataract surgery.

Study Type

Observational

Enrollment (Anticipated)

100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population will include approximately 100 patients, taking warfarin and that are candidates for cataract surgery. These patients will continue their warfarin therapy as usual and at the same dose, before and after the operation.

Description

Inclusion Criteria:

people taking warfarin
candidates for cataract surgery

Exclusion Criteria:

age <18 years
pregnant women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Case-Only
Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
INR levels (international normalized ratio) - change is being assessed Time Frame: 1 week, 2 weeks, 3 weeks and 4 weeks after taking Voltaren Optha 0.1%	change is being assessed	1 week, 2 weeks, 3 weeks and 4 weeks after taking Voltaren Optha 0.1%

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wolfson Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Anticipated)

May 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

May 10, 2016

First Submitted That Met QC Criteria

May 24, 2016

First Posted (Estimate)

May 25, 2016

Study Record Updates

Last Update Posted (Estimate)

June 1, 2016

Last Update Submitted That Met QC Criteria

May 29, 2016

Last Verified