Status:
COMPLETED
Bromfenac BID Plus Prednisolone Acetate BID Versus Bromfenac BID Plus Prednisolone QID for the Prevention of Cystoid Macular Edema and Retinal Thickening
Lead Sponsor:
Center For Excellence In Eye Care
Conditions:
Cystoid Macular Edema,
Retinal Thickening
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 c...
Eligibility Criteria
Inclusion
- · 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
- · 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
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT00469781
Start Date
May 1 2007
End Date
September 1 2008
Last Update
September 25 2008
Active Locations (1)
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1
The Center for Excellence in Eye Care
Miami, Florida, United States, 33176