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

This study has been completed.
Sponsor:
Information provided by:
Innovative Medical
ClinicalTrials.gov Identifier:
NCT00433225
First received: February 7, 2007
Last updated: September 5, 2007
Last verified: September 2007
  Purpose

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:

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov 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

Additional relevant MeSH terms:
Methylprednisolone acetate
Prednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Ketorolac
Ketorolac Tromethamine
Prednisolone hemisuccinate
Prednisolone phosphate
Gatifloxacin
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents

ClinicalTrials.gov processed this record on August 28, 2014