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To compare the efficacy of twice-daily topical bromfenac (Xibrom) ophthalmic solution alone versus twice-daily topical Xibrom with prednisolone acetate 1% three-times daily on visual acuity and OCT measurements.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Group 1: Xibrom, Optive |
|
| 2 | Active Comparator | Group 2: Xibrom, Pred Forte |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xibrom, and Optive | Drug | Xibrom: two drops a day, three days before surgery and 21 days after surgery. Optive: three times a day for 21 days after surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| OCT | 2-4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity | 2-4 months |
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Inclusion Criteria:
Male or female at least 18 years of age.
Exclusion Criteria:
Any known contraindications to any study medication or their component
Presence of uncontrolled systemic disease
Required use of other ocular medications during the study
o Artificial tears may be used
Diabetics with any clinically evident or history of retinopathy
Individuals with age-related macular changes, epi-retinal membranes, other retino-vascular diseases and/or other macular disorders thought to have a less than 20/25 surgical outcome expectation
Abnormal pre-operative OCT (if obtainable)
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| Name | Affiliation | Role |
|---|---|---|
| James Gills, MD | St. Luke's Cataract and Laser Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Luke's Cataract and Laser institute | Tarpon Springs | Florida | 34688 | United States |
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| Xibrom and Pred Forte | Drug | Xibrom: two drops a day, three days before surgery and 21 days after surgery. Pred Forte: three times a day for 21 days after surgery. |
|
| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C053083 | bromfenac |
| C009935 | prednisolone acetate |
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