Status:
COMPLETED
Determination of Optimum Duration of Treatment With Bromfenac (Xibrom) Eyedrops Following Cataract Surgery
Lead Sponsor:
Bp Consulting, Inc
Conditions:
Cataracts
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
The objective of this study is to determine if an extension of bromfenac BID monotherapy is effective in the decreasing retinal thickening post cataract IOL placement surgery. No studies exist on how ...
Eligibility Criteria
Inclusion
- Male or female \>18 years of age scheduled to undergo bilateral cataract surgery
- Patients with systemic diseases will be enrolled only if there are no ocular manifestations of their disease (e.g. diabetics with normal retinal exams)
- Expected visual outcome of BCVA \> \[greater than or equal to\] 20/30 postoperatively
- Ability to provide informed consent, take study medications as directed, and likely to complete all study visits
Exclusion
- Known contraindication to any study medication or any of their components
- Required use of ocular medications other than the study medications during the study
- Significant AMD, epi-retinal membrane, retinal vein occlusion, diabetic macular edema, or any macular disease predisposing them to cystoid macular edema.
- Posterior capsule rupture, Vitreous loss during surgery or any other complication that in the surgeon's opinion, could reduce potential for targeted visual outcome
- Anticipated need for mechanical iris dilating devices
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00758199
Start Date
July 1 2008
End Date
January 1 2010
Last Update
March 15 2012
Active Locations (1)
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1
Altos Eye Physicians
Los Altos, California, United States, 94024