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

This study has been completed.
Sponsor:
Information provided by:
Veroia General Hospital
ClinicalTrials.gov Identifier:
NCT00992355
First received: October 8, 2009
Last updated: NA
Last verified: October 2009
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. 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
Endpoint Classification: Efficacy Study
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:

MedlinePlus related topics: Cataract
U.S. FDA Resources

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

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:

  • Disruption of the anterior lens capsule
  • Age-related macular degeneration
  • Proliferative diabetic retinopathy
  • Glaucoma
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00992355

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

No publications provided

ClinicalTrials.gov Identifier: NCT00992355     History of Changes
Other Study ID Numbers: VGH-EYE01
Study First Received: October 8, 2009
Last Updated: October 8, 2009
Health Authority: Greece: Ethics Committee

Keywords provided by Veroia General Hospital:
Cataract
Phacoemulsification
Treatment duration

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 May 19, 2013