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NCT02782338 Clinical Trial

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

Blood Coagulation Disorders Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT02782338
Other study ID # WolfsonMC
Secondary ID
Status Not yet recruiting
Phase N/A
First received May 10, 2016
Last updated May 29, 2016
Start date May 2016
Est. completion date December 2017

Study information
Verified date May 2016
Source Wolfson Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date December 2017
Est. primary completion date May 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

- people taking warfarin

- candidates for cataract surgery

Exclusion Criteria:

- age <18 years

- pregnant women

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• Voltaren ophtha 0.1%
All study patients will be treated with Voltaren ophtha 0.1% after cataract surgery

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Wolfson Medical Center

Outcome
Type Measure Description Time frame Safety issue
Primary INR levels (international normalized ratio) - change is being assessed change is being assessed 1 week, 2 weeks, 3 weeks and 4 weeks after taking Voltaren Optha 0.1% Yes
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