Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Information provided by:
Innovative Medical Identifier:
First received: February 7, 2007
Last updated: September 5, 2007
Last verified: September 2007

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.

Condition Intervention Phase
Macula Thickening
Drug: Prednisolone Acetate
Drug: Ketorolac 0.4%
Drug: Gatifloxacin 0.3%
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind

Resource links provided by NLM:

Further study details as provided by Innovative Medical:


Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both

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
  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: NCT00433225

United States, New York
Ophthalmic Consultants of Long Island
Rockville Centre, New York, United States, 11570
Sponsors and Collaborators
Innovative Medical
Principal Investigator: Eric Donnenfeld Ophthalmic Consultants of Long Island
  More Information

No publications provided Identifier: NCT00433225     History of Changes
Other Study ID Numbers: 5293
Study First Received: February 7, 2007
Last Updated: September 5, 2007
Health Authority: United States: Institutional Review Board processed this record on February 27, 2015