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

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ClinicalTrials.gov Identifier: NCT02782338
Recruitment Status : Unknown
Verified May 2016 by Lili karmona, Wolfson Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : May 25, 2016
Last Update Posted : June 1, 2016
Sponsor:
Information provided by (Responsible Party):
Lili karmona, Wolfson Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment
Blood Coagulation Disorders 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.


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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: 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
Study Start Date : May 2016
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : December 2017



Intervention Details:
  • Drug: Voltaren ophtha 0.1%
    All study patients will be treated with Voltaren ophtha 0.1% after cataract surgery
    Other Name: voltaren drops


Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

Inclusion Criteria:

  • people taking warfarin
  • candidates for cataract surgery

Exclusion Criteria:

  • age <18 years
  • pregnant women

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Responsible Party: Lili karmona, Dr., Ophthalmologist, Wolfson Medical Center
ClinicalTrials.gov Identifier: NCT02782338     History of Changes
Other Study ID Numbers: WolfsonMC
First Posted: May 25, 2016    Key Record Dates
Last Update Posted: June 1, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Lili karmona, Wolfson Medical Center:
warfarin
Voltaren eye drops
INR
Additional relevant MeSH terms:
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Diclofenac
Hemostatic Disorders
Blood Coagulation Disorders
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Warfarin
Ophthalmic Solutions
Anticoagulants
Pharmaceutical Solutions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action