Determination of Optimum Duration of Treatment With Bromfenac (Xibrom) Eyedrops Following Cataract Surgery
Information source: Bp Consulting, Inc
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cataracts
Intervention: Bromfenac (Drug); Moxifloxacin hydrochloride (Drug); Prednisolone Acetate (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Bp Consulting, Inc Overall contact:
Michelle Chabot, Phone: (714) 246-9581, Email: michelle_bpconsulting@yahoo.com
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 long to treat with an NSAID post cataract IOL placement surgery.
Currently, NSAID therapy post IOL placement surgery is in conjunction with steroid
treatment, lasting approximately 3 weeks. This study is designed to examine if there is
benefit to extending NSAID monotherapy in regards to macular thickening and the incidence of
CME.
Clinical Details
Official title: Determination of Optimum Duration of Treatment With Bromfenac (Xibrom) Eyedrops Following Cataract Surgery
Study design: Treatment, Randomized, Single Blind (Investigator), Parallel Assignment, Efficacy Study
Primary outcome: OCT with macular thickening
Secondary outcome: Incidence of CME
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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
Locations and Contacts
Michelle Chabot, Phone: (714) 246-9581, Email: michelle_bpconsulting@yahoo.com
Altos Eye Physicians, 762 Altos Oaks Drive, Suite 1 Los Altos, Ca 94024, California 94024, United States; Recruiting
David Chang, M.D, Phone: 650-948-9123, Email: dceye@earthlink.net
Additional Information
Starting date: July 2008
Ending date: June 2009
Last updated: April 7, 2009
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