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

This study has been completed.
Sponsor:
Information provided by:
Veroia General Hospital
ClinicalTrials.gov Identifier:
NCT01103401
First received: April 13, 2010
Last updated: NA
Last verified: April 2010
History: No changes posted
  Purpose

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.


Condition Intervention
Cataract
 Drug: Drug: Tobramycin 0.3% - Dexamethasone 0.1%
Drug: Drug: Tobramycin-Dexamethasone plus Ketorolac tromethamine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Ketorolac Plus Tobramycin/Dexamethasone vs. Tobramycin/Dexamethasone After Uneventful Phacoemulsification Surgery

Resource links provided by NLM:

MedlinePlus related topics: Cataract
U.S. FDA Resources

Further study details as provided by Veroia General Hospital:

Enrollment: 145
Study Start Date: October 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Tobramycin/Dexamethasone Drug: Drug: Tobramycin 0.3% - Dexamethasone 0.1%
one drop four times per day
Other Name: 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 Name: Acular
Active Comparator: Tobramycin/Dexamethasone plus Ketorolac tromethamine Drug: Drug: Tobramycin 0.3% - Dexamethasone 0.1%
one drop four times per day
Other Name: 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 Name: Acular

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.

  Eligibility

Ages Eligible for Study:   55 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01103401

Sponsors and Collaborators
Veroia General Hospital
Investigators
Study Director: Leonidas E Papazisis, Director leopapazisis@yahoo.gr
  More Information

No publications provided

Responsible Party: Department of Ophthalmology, Veroia General Hospital
ClinicalTrials.gov Identifier: NCT01103401     History of Changes
Other Study ID Numbers: VGH-EYE02
Study First Received: April 13, 2010
Last Updated: April 13, 2010
Health Authority: Greece: Ethics Committee

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases
Tobramycin
Dexamethasone acetate
Dexamethasone
Ketorolac Tromethamine
Ketorolac
Dexamethasone 21-phosphate
BB 1101
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents
 Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors

ClinicalTrials.gov processed this record on June 18, 2013