Topical 0.4% Ketorolac and Vitreoretinal Surgery

May 12, 2014 updated by: Stephen Kim, MD, Emory University

Topical 0.4% Ketorolac for the Inhibition of Miosis During Vitreoretinal Surgery: a Randomized, Placebo-controlled, Double-masked Study

To determine whether use of topical 0.4% ketorolac has any effect on pupil size during vitreoretinal surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Other outcomes will be to assess postoperative pain and inflammation and visual acuity.

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory Eye Clinic

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age of 18, routine elective vitrectomy

Exclusion Criteria:

  • history of trauma, uveitis, prior intraocular surgery within 3 months, requirement of mechanical pupil dilation, prior inclusion of other eye

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: B
Drug: Ketorolac
Topical use before surgery
Other Names:
  • Acular LS
Placebo Comparator: A
Drug: Ketorolac
Topical use before surgery
Other Names:
  • Acular LS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in pupil size during vitreoretinal surgery
Time Frame: Surgery
Surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Postoperative pain and inflammation
Time Frame: 1 day
1 day

Collaborators and Investigators

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

Sponsor

Emory University

Investigators

  • Principal Investigator: Stephen J Kim, MD, Emory University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

November 1, 2006

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

December 17, 2007

First Submitted That Met QC Criteria

December 17, 2007

First Posted (Estimate)

December 19, 2007

Study Record Updates

Last Update Posted (Estimate)

May 14, 2014

Last Update Submitted That Met QC Criteria

May 12, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00000517

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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