Efficacy of Topical Ketorolac Versus Placebo for Improving Visual Outcomes Following Multifocal IOL Implantation

The purpose of this study was to evaluate the efficacy of ketorolac 0.4% on quality of vision and macula thickening in patients undergoing cataract surgery using the ReStor® multifocal IOL...

Date First Received: February 7, 2007

Last Updated: September 5, 2007

Verified by: Innovative Medical, September 2007

Clinical Trial Phase: Phase 4 | Start Date: 

Overall Status: Completed

Brief Summary

Condition Keyword(s):

The purpose of this study was to evaluate the efficacy of ketorolac 0.4% on quality of vision and macula thickening in patients undergoing cataract surgery using the ReStor® multifocal IOL.

Study Type: Interventional

Study Design: Randomized, Single Blind, Active Control, Parallel Assignment

Intervention(s) in this Clinical Trial

  • Drug: Prednisolone Acetate
  • Drug: Ketorolac 0.4%
  • Drug: Gatifloxacin 0.3%

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Males or females > 50 years old
  • Scheduled to undergo bilateral phacoemulsification with implantation of a multifocal
  • IOL.
  • Likely to complete all study visits and able to provide informed consent
  • Visual potential of 20/25 or better

Exclusion Criteria:

  • · Prior use of topical ketorolac
  • Known contraindications to any study medication or ingredients
  • Active ocular diseases or uncontrolled systemic disease
  • Active ocular allergies

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 50 Years

Maximum Age for this Clinical Trial: N/A

Clinical Trial Sponsor Information

Lead Sponsor: Innovative Medical

Overall Clinical Trial Officials and Contacts

Eric Donnenfeld Principal Investigator Ophthalmic Consultants of Long Island  

Additional Information

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00433225

Study ID Number: 5293

ClinicalTrials.gov Identifier: NCT00433225

Health Authority: United States: Institutional Review Board

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