Ketorolac Plus Tobramycin/Dexamethasone Versus Tobramycin/Dexamethasone After Uneventful Phacoemulsification Surgery

April 14, 2015 updated by: Veroia General Hospital

Ketorolac Plus Tobramycin/Dexamethasone vs. Tobramycin/Dexamethasone After Uneventful Phacoemulsification Surgery

This randomized controlled trial compares two regimens of topical therapy:

  • tobramycin 0.3% - dexamethasone 0.1% (TobraDex®, Alcon), one drop four times/day
  • combination of tobramycin 0.3% - dexamethasone 0.1% (TobraDex®, Alcon), one drop four times/day, plus Ketorolac tromethamine 0.5% (Acular®, Allergan), one drop three times/day.

Patients are independently assessed by two ophthalmologists. On days 7,14,21,28 patients are evaluated for

  • corneal edema
  • conjunctival hyperemia
  • anterior chamber (Tyndall) reaction.

The investigators purpose was to evaluate the benefit of adding a non-steroid agent to an antibiotic/steroid combination after uneventful phacoemulsification. Adopting a weekly follow-up, to gain insight into the optimal duration of postoperative treatment and to examine whether risk factors for inflammation exist.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients were randomized to: i) tobramycin 0.3% - dexamethasone 0.1% one drop qid (TD group, n=72, 28 days) and ii) combination of tobramycin 0.3% - dexamethasone 0.1%, one drop qid, plus Ketorolac tromethamine 0.5%, one drop tid (TD-K group, n=73, 28 days). Patients undergoing vitrectomy due to posterior capsule rupture were excluded. On days 7, 14, 21, 28, the frequency of inflammation-related signs [corneal edema, conjunctival hyperemia, anterior chamber (Tyndall) reaction], as well as the best corrected visual acuity (BCVA) were measured. On day 21, logistic regression was performed to evaluate risk factors for inflammation.

Study Type

Interventional

Enrollment (Actual)

145

Phase

  • Not Applicable

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

55 years to 95 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • phacoemulsification (due to cataract)
  • uneventful phacoemulsification surgery

Exclusion Criteria:

  • history of intraocular surgery in the operated eye,
  • any previous episode of uveitis in the operated eye,
  • severe systemic disease (heart failure NYHA stage III of IV, end-stage renal failure, pulmonary failure, patients receiving chemotherapy),
  • regular, systemic use of steroid or non-steroid anti-inflammatory drugs during the last three months
  • disruption of the anterior lens capsule

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Tobramycin/Dexamethasone
Drug: Drug: Tobramycin 0.3% - Dexamethasone 0.1%
one drop four times per day
Other Names:
  • Tobradex
Drug: Drug: Tobramycin-Dexamethasone plus Ketorolac tromethamine
Tobramycin-Dexamethasone one drop four times per day and Ketorolac tromethamine one drop three times per day
Other Names:
  • Acular
ACTIVE_COMPARATOR: Tobramycin/Dexamethasone plus Ketorolac tromethamine
Drug: Drug: Tobramycin 0.3% - Dexamethasone 0.1%
one drop four times per day
Other Names:
  • Tobradex
Drug: Drug: Tobramycin-Dexamethasone plus Ketorolac tromethamine
Tobramycin-Dexamethasone one drop four times per day and Ketorolac tromethamine one drop three times per day
Other Names:
  • Acular

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Visual acuity, corneal edema, Tyndall reaction, redness
Time Frame: 1,7,14,28 post-operative day, Up to 28 days
1,7,14,28 post-operative day, Up to 28 days

Collaborators and Investigators

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

Sponsor

Veroia General Hospital

Investigators

  • Study Director: Leonidas E Papazisis, Director, leopapazisis@yahoo.gr

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

October 1, 2009

Primary Completion (ACTUAL)

January 1, 2010

Study Completion (ACTUAL)

January 1, 2010

Study Registration Dates

First Submitted

April 13, 2010

First Submitted That Met QC Criteria

April 13, 2010

First Posted (ESTIMATE)

April 14, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

April 15, 2015

Last Update Submitted That Met QC Criteria

April 14, 2015

Last Verified

April 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VGH-EYE02

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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