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The objective of this study is to determine if twice-daily dosing of prednisolone (Pred Forte) is as effective as four-times-daily dosing of prednisolone for the prevention of retinal thickening and cystoid macular edema (CME) when either regimen is used concomitantly with twice-daily bromfenac.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator |
| |
| 2 | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2. Xibrom (Bromfenac) | Drug | Group 1 and 2: 1 drop(Instill one drop in the eye that was operated on twice daily)3 days prior to surgery and 4 doses during dilation immediately before the procedure. Use for 4 weeks after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Cystoid Macular Edema | 11 months |
| Measure | Description | Time Frame |
|---|---|---|
| Retinal Thickening | 11 months |
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Inclusion Criteria:
· Male or female > 18 years of age scheduled to undergo cataract surgery
Exclusion Criteria:
· Known contraindication to any study medication or any of their components
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| Name | Affiliation | Role |
|---|---|---|
| Carlos Buznego, MD | The Center for Excellence in Eye Care | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Center for Excellence in Eye Care | Miami | Florida | 33176 | United States |
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| 1. Pred Forte | Drug | Group 1 Instill one drop in the eye that was operated on four times a day starting on day of surgery and use for four weeks. Group 2 Instill one drop in the eye that was operated on twice a day starting on day of surgery and use for four weeks. |
|
| ID | Term |
|---|---|
| D008269 | Macular Edema |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C053083 | bromfenac |
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