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Tobramycin-Dexamethasone Versus Tobramycin-Dexamethasone Plus Ketorolac After Phacoemulsification Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00992355
First Posted: October 9, 2009
Last Update Posted: October 9, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Veroia General Hospital
  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. The topical treatment is administered for 28 days after phacoemulsification.

Patients are independently assessed by two ophthalmologists. On day 28, patients are evaluated for

  • corneal edema
  • conjunctival redness
  • anterior chamber reaction. Moreover, the cases necessitating continuation of treatment are compared in the two groups on day 28 and 42.

Condition Intervention
Cataract Drug: Tobramycin 0.3% - Dexamethasone 0.1% Drug: Tobramycin 0.3% - Dexamethasone 0.1% plus Ketorolac tromethamine 0.5%

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tobramycin 0.3% - Dexamethasone 0.1% Versus Tobramycin 0.3% - Dexamethasone 0.1% Plus Ketorolac Tromethamine 0.5% After Phacoemulsification Surgery. A Randomized Trial

Resource links provided by NLM:


Further study details as provided by Veroia General Hospital:

Enrollment: 97
Study Start Date: January 2009
Study Completion Date: April 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Tobramycin 0.3% - Dexamethasone 0.1% Drug: Tobramycin 0.3% - Dexamethasone 0.1%
Active Comparator: Tobramycin-Dexamethasone plus Ketorolac tromethamine Drug: Tobramycin 0.3% - Dexamethasone 0.1% plus Ketorolac tromethamine 0.5%

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Phacoemulsification (due to cataract)
  • Uneventful phacoemulsification surgery

Exclusion Criteria:

  • Disruption of the anterior lens capsule
  • Age-related macular degeneration
  • Proliferative diabetic retinopathy
  • Glaucoma
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00992355


Locations
Greece
Department of Ophthalmology, Veroia General Hospital
Veroia, Greece, 59100
Sponsors and Collaborators
Veroia General Hospital
  More Information

ClinicalTrials.gov Identifier: NCT00992355     History of Changes
Other Study ID Numbers: VGH-EYE01
First Submitted: October 8, 2009
First Posted: October 9, 2009
Last Update Posted: October 9, 2009
Last Verified: October 2009

Keywords provided by Veroia General Hospital:
Cataract
Phacoemulsification
Treatment duration

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases
Dexamethasone acetate
Dexamethasone
Ketorolac
Ketorolac Tromethamine
BB 1101
Tobramycin
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Anti-Bacterial Agents