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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 | Active Comparator | Moxifloxacin |
|
| 3 | Placebo Comparator | Prednisolone Acetate |
|
| 1 | Active Comparator | Bromfenac |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bromfenac | Drug | Group 1: Bromfenac BID for 3 weeks Group 2: Bromfenac BID for 6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| OCT with macular thickening | 3-6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of CME | 3-6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Altos Eye Physicians | Los Altos | California | 94024 | United States |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C053083 | bromfenac |
| D000077266 | Moxifloxacin |
| C009935 | prednisolone acetate |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| Moxifloxacin hydrochloride | Drug | Group 1 and Group 2:Moxifloxacin hydrochloride 1 day prior to surgery-continue for six days after surgery. |
|
|
| Prednisolone Acetate | Drug | Group 1 and Group 2:Prednisolone Acetate for 3 weeks in a tapering schedule (week 1: TID; week 2: BID, week 3:QD). |
|
|
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |