Ketorolac vs. Steroid in the Prevention of CME
Information source: Innovative Medical
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cataract
Intervention: Ketorolac, Prednisolone Acetate (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Innovative Medical Official(s) and/or principal investigator(s):
John Wittpenn, MD, Principal Investigator, Affiliation: Ophthalmic Consultants of Long Island
Summary
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.
Clinical Details
Official title: A Masked Comparison of Acular LS Plus Steroid Versus Steroid Alone for the Prevention of Macular Leakage in Cataract Patients
Study design: Randomized, Single Blind, Active Control, Parallel Assignment
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Dr. Wittpenn, Stony Brook, New York 11790, United States
Additional Information
Last updated: January 15, 2007
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