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

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ClinicalTrials.gov Identifier: NCT00433225
Recruitment Status : Completed
First Posted : February 9, 2007
Last Update Posted : September 10, 2007
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Macula Thickening Drug: Prednisolone Acetate Drug: Ketorolac 0.4% Drug: Gatifloxacin 0.3% Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single

Resource links provided by the National Library of Medicine

Drug Information available for: Ketorolac
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00433225


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

ClinicalTrials.gov Identifier: NCT00433225     History of Changes
Other Study ID Numbers: 5293
First Posted: February 9, 2007    Key Record Dates
Last Update Posted: September 10, 2007
Last Verified: September 2007

Additional relevant MeSH terms:
Prednisolone acetate
Methylprednisolone acetate
Prednisolone
Ketorolac
Ketorolac Tromethamine
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Gatifloxacin
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Neuroprotective Agents