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Ketorolac vs. Steroid in the Prevention of CME

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00348244
First Posted: July 4, 2006
Last Update Posted: January 17, 2007
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:
Innovative Medical
  Purpose
Evaluate if the incidence of sub clinical CME can be significantly reduced by use of peri-operative Acular LS plus Pred Forte when compared with Pred Forte alone in normal cataract patients.

Condition Intervention Phase
Cataract Drug: Ketorolac, Prednisolone Acetate Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Official Title: A Masked Comparison of Acular LS Plus Steroid Versus Steroid Alone for the Prevention of Macular Leakage in Cataract Patients

Resource links provided by NLM:


Further study details as provided by Innovative Medical:

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • · Male or female > 18 years of age scheduled to undergo cataract surgery with surgeon expectation of 20/20 BCVA postoperatively

    • Must be in good general health. Patients with systemic diseases will be enrolled only if there are no ocular manifestations of their disease (ie diabetics with normal retinal exams)
    • Ability to provide informed consent and likely to complete all study visits

Exclusion Criteria:

  • · Known contraindication to any study medication or any of their components

    • Uncontrolled systemic disease
    • Required use of ocular medications other than the study medications during the study
    • Abnormal pre-operative OCTs if obtainable
    • Diabetic patients with a history of macular edema or diabetic retinopathy
    • AMD patients with less than a 20/20 surgical outcome expectation, epi-retinal membranes, retinal vein occlusion, or any pre-existing macular disease
  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): NCT00348244


Locations
United States, New York
Dr. Wittpenn
Stony Brook, New York, United States, 11790
Sponsors and Collaborators
Innovative Medical
Investigators
Principal Investigator: John Wittpenn, MD Ophthalmic Consultants of Long Island
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00348244     History of Changes
Other Study ID Numbers: 5152
First Submitted: June 30, 2006
First Posted: July 4, 2006
Last Update Posted: January 17, 2007
Last Verified: January 2007

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases
Prednisolone acetate
Methylprednisolone acetate
Prednisolone
Ketorolac
Ketorolac Tromethamine
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
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