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Ketorolac vs. Steroid in the Prevention of CME

This study has been completed.
Information provided by:
Innovative Medical Identifier:
First received: June 30, 2006
Last updated: January 15, 2007
Last verified: January 2007
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:


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

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
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Please refer to this study by its identifier: NCT00348244

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

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00348244     History of Changes
Other Study ID Numbers: 5152
Study First Received: June 30, 2006
Last Updated: January 15, 2007

Additional relevant MeSH terms:
Lens Diseases
Eye Diseases
Prednisolone acetate
Methylprednisolone acetate
Ketorolac Tromethamine
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Autonomic Agents processed this record on September 21, 2017