NCT02782338

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2016

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

May 10, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 25, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

June 1, 2016

Status Verified

May 1, 2016

Enrollment Period

1 year

First QC Date

May 10, 2016

Last Update Submit

May 29, 2016

Conditions

Blood Coagulation Disorders

Keywords

warfarinVoltaren eye dropsINR

Outcome Measures

Primary Outcomes (1)

  • 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%

Interventions

Voltaren ophtha 0.1%DRUG

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

Also known as: voltaren drops

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • people taking warfarin
  • candidates for cataract surgery

You may not qualify if:

  • age \<18 years
  • pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Blood Coagulation Disorders

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr., Ophthalmologist

Study Record Dates

First Submitted

May 10, 2016

First Posted

May 25, 2016

Study Start

May 1, 2016

Primary Completion

May 1, 2017

Study Completion

December 1, 2017

Last Updated

June 1, 2016

Record last verified: 2016-05