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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
October 8, 2009
October 9, 2009
October 9, 2009
January 2009
March 2009   (Final data collection date for primary outcome measure)
Not Provided
Not Provided
No Changes Posted
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Tobramycin-Dexamethasone Versus Tobramycin-Dexamethasone Plus Ketorolac After Phacoemulsification Surgery
Tobramycin 0.3% - Dexamethasone 0.1% Versus Tobramycin 0.3% - Dexamethasone 0.1% Plus Ketorolac Tromethamine 0.5% After Phacoemulsification Surgery. A Randomized Trial

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Cataract
  • Drug: Tobramycin 0.3% - Dexamethasone 0.1%
  • Drug: Tobramycin 0.3% - Dexamethasone 0.1% plus Ketorolac tromethamine 0.5%
  • Active Comparator: Tobramycin 0.3% - Dexamethasone 0.1%
    Intervention: Drug: Tobramycin 0.3% - Dexamethasone 0.1%
  • Active Comparator: Tobramycin-Dexamethasone plus Ketorolac tromethamine
    Intervention: Drug: Tobramycin 0.3% - Dexamethasone 0.1% plus Ketorolac tromethamine 0.5%
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
97
April 2009
March 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
55 Years to 95 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Greece
 
 
NCT00992355
VGH-EYE01
Yes
Not Provided
Not Provided
Not Provided
Veroia General Hospital
Not Provided
Not Provided
Veroia General Hospital
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP