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Ketorolac vs. Steroid in the Prevention of CME

This study has been completed.
Sponsor:
Information provided by:
Innovative Medical
ClinicalTrials.gov Identifier:
NCT00348244
First received: June 30, 2006
Last updated: January 15, 2007
Last verified: January 2007
History of Changes

June 30, 2006
January 15, 2007
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Complete list of historical versions of study NCT00348244 on ClinicalTrials.gov Archive Site
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Ketorolac vs. Steroid in the Prevention of CME
A Masked Comparison of Acular LS Plus Steroid Versus Steroid Alone for the Prevention of Macular Leakage in Cataract Patients

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.
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Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind
Cataract
Drug: Ketorolac, Prednisolone Acetate
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Wittpenn JR, Silverstein S, Heier J, Kenyon KR, Hunkeler JD, Earl M; Acular LS for Cystoid Macular Edema (ACME) Study Group. A randomized, masked comparison of topical ketorolac 0.4% plus steroid vs steroid alone in low-risk cataract surgery patients. Am J Ophthalmol. 2008 Oct;146(4):554-560. Epub 2008 Jul 2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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
Both
18 Years and older
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Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00348244
5152
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Innovative Medical
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Principal Investigator: John Wittpenn, MD Ophthalmic Consultants of Long Island
Innovative Medical
January 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP