Cataracts
Conditions
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 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.
Interventions
DRUGBromfenac
Group 1: Bromfenac BID for 3 weeks Group 2: Bromfenac BID for 6 weeks
Group 1 and Group 2:Moxifloxacin hydrochloride 1 day prior to surgery-continue for six days after surgery.
DRUGPrednisolone Acetate
Group 1 and Group 2:Prednisolone Acetate for 3 weeks in a tapering schedule (week 1: TID; week 2: BID, week 3:QD).
Sponsors
Bp Consulting, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OCT with macular thickening | 3-6 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of CME | 3-6 weeks |
Countries
United States
Outcome results
None listed