Bromfenac BID Plus Prednisolone Acetate BID Versus Bromfenac BID Plus Prednisolone QID for the Pr… (NCT00469781) | Clinical Trial Compass
CompletedPhase 4
Bromfenac BID Plus Prednisolone Acetate BID Versus Bromfenac BID Plus Prednisolone QID for the Prevention of Cystoid Macular Edema and Retinal Thickening
United States95 participantsStarted 2007-05
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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