Bromfenac BID Plus Prednisolone Acetate BID Versus Bromfenac BID Plus Prednisolone QID for the Prevention of Cystoid Macular Edema and Retinal Thickening
Information source: Center For Excellence In Eye Care
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cystoid Macular Edema,; Retinal Thickening
Intervention: 2. Xibrom (Bromfenac) (Drug); 1. Pred Forte (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Center For Excellence In Eye Care Official(s) and/or principal investigator(s):
Carlos Buznego, MD, Principal Investigator, Affiliation: The Center for Excellence in Eye Care
Overall contact:
Carlos Buznego, MD, Phone: 305-598-2020, Email: cbuz@comcast.net
Summary
The objective of this study is to determine if twice-daily dosing of prednisolone (Pred
Forte) is as effective as four-times-daily dosing of prednisolone for the prevention of
retinal thickening and cystoid macular edema (CME) when either regimen is used concomitantly
with twice-daily bromfenac.
Clinical Details
Study design: Prevention, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment
Primary outcome: Cystoid Macular Edema
Secondary outcome: Retinal Thickening
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
- 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)
- Expected visual outcome of 20/25 or better.
- 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
- Diabetic patients with a history of macular edema or diabetic retinopathy
- AMD, epi-retinal membranes, retinal vein occlusion, or any pre-existing macular
disease
- Only one eye of each patient can be enrolled
Locations and Contacts
Carlos Buznego, MD, Phone: 305-598-2020, Email: cbuz@comcast.net
The Center for Excellence in Eye Care, Miami, Florida 33176, United States; Recruiting
Carlos Buznego, MD, Phone: 305-598-2020, Email: cbuz@comcast.net
Additional Information
Starting date: May 2007
Ending date: March 2008
Last updated: January 7, 2008
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