Bromfenac BID Plus Prednisolone Acetate BID Versus Bromfenac BID Plus Prednisolone QID for the Prevention of Cystoid Macular Edema and Retinal Thickening
NCT ID: NCT00469781
Last Updated: 2008-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
95 participants
INTERVENTIONAL
2007-05-31
2008-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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1
1. Pred Forte
Group 1 Instill one drop in the eye that was operated on four times a day starting on day of surgery and use for four weeks.
Group 2 Instill one drop in the eye that was operated on twice a day starting on day of surgery and use for four weeks.
2
2. Xibrom (Bromfenac)
Group 1 and 2: 1 drop(Instill one drop in the eye that was operated on twice daily)3 days prior to surgery and 4 doses during dilation immediately before the procedure. Use for 4 weeks after surgery.
Interventions
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2. Xibrom (Bromfenac)
Group 1 and 2: 1 drop(Instill one drop in the eye that was operated on twice daily)3 days prior to surgery and 4 doses during dilation immediately before the procedure. Use for 4 weeks after surgery.
1. Pred Forte
Group 1 Instill one drop in the eye that was operated on four times a day starting on day of surgery and use for four weeks.
Group 2 Instill one drop in the eye that was operated on twice a day starting on day of surgery and use for four weeks.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Center For Excellence In Eye Care
OTHER
Responsible Party
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The Center for Excellence in Eye Care
Principal Investigators
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Carlos Buznego, MD
Role: PRINCIPAL_INVESTIGATOR
The Center for Excellence in Eye Care
Locations
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The Center for Excellence in Eye Care
Miami, Florida, United States
Countries
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Other Identifiers
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5306
Identifier Type: -
Identifier Source: org_study_id