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.

Study Type: Interventional

Study Design: Prevention, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment

Study Primary Completion Date: March 2008

Intervention(s) in this Clinical Trial

• Drug: 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.
• Drug: 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.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
• Other: 2

Primary Measures

• Cystoid Macular Edema
  • Time Frame: 11 months
    Safety Issue?: No

Secondary Measures

• Retinal Thickening
  • Time Frame: 11 months
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Center For Excellence In Eye Care

Overall Clinical Trial Officials and Contacts

Carlos Buznego, MD Principal Investigator The Center for Excellence in Eye Care  

Overall Contact: Carlos Buznego, MD 305-598-2020 cbuz@comcast.net

Information obtained from ClinicalTrials.gov on August 28, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00469781

Study ID Number: 5306

ClinicalTrials.gov Identifier: NCT00469781

Health Authority: United States: Institutional Review Board