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: September 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  

Information obtained from ClinicalTrials.gov on July 02, 2009

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