Clinical Trial: Randomized, Masked Comparison of Bromfenac and Besifloxacin BID With Either Prednisolone BID or Loteprednol 0.5% BID for Prevention of Retinal Thickening and CME Following Phacoemulsification

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Randomized, Masked Comparison of Bromfenac and Besifloxacin BID With Either Prednisolone BID or Loteprednol 0.5% BID for Prevention of Retinal Thickening and CME Following Phacoemulsification

Brief Summary: The purpose of this study is to determine if Lotemax eye drops are at least as effective as Pred Forte eye drops, which are the standard of care after cataract surgery.

Detailed Summary: Prednisolone 1%, a topical steroid, is considered standard of care following cataract surgery to reduce inflammation. We aim to determine if Lotemax is at least as effective as Prednisolone. If so, these findings would demonstrate that physicians have other treatment options to consider.
Sponsor: Innovative Medical

Current Primary Outcome: Prevention Of Retinal Thickening [ Time Frame: 1 Year ]

  • OCT (optical coherence tomography) with macular thickening
  • Incidence of CME ( cystoids macular edema)
  • BCVA (best corrected visual acuity)
  • UCVA (uncorrected visual acuity)
  • Central corneal thickness


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Innovative Medical

Dates:
Date Received: August 31, 2010
Date Started: September 2010
Date Completion: October 2012
Last Updated: June 13, 2012
Last Verified: June 2012