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

• Conditions: Blood Coagulation Disorders

• Registration Number: NCT02782338
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2016-05
• Study Start: 2016-05
• Study First Submitted: 2016-05-10
• Study First Submitted QC: 2016-05-24
• Study First Posted: 2016-05-25
• Last Update Submitted: 2016-05-29
• Last Update Posted: 2016-06-01
• Primary Completion: 2017-05
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• people taking warfarin
• candidates for cataract surgery

Exclusion Criteria

• age <18 years
• pregnant women

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
INR levels (international normalized ratio) - change is being assessed	1 week, 2 weeks, 3 weeks and 4 weeks after taking Voltaren Optha 0.1%	change is being assessed