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

This study has been completed.
Information provided by:
Veroia General Hospital Identifier:
First received: October 8, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted

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
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: 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%


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00992355

Department of Ophthalmology, Veroia General Hospital
Veroia, Greece, 59100
Sponsors and Collaborators
Veroia General Hospital
  More Information Identifier: NCT00992355     History of Changes
Other Study ID Numbers: VGH-EYE01
Study First Received: October 8, 2009
Last Updated: October 8, 2009

Keywords provided by Veroia General Hospital:
Treatment duration

Additional relevant MeSH terms:
Lens Diseases
Eye Diseases
Dexamethasone acetate
Ketorolac Tromethamine
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
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
Sensory System Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors processed this record on May 22, 2017