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| ID | Type | Description | Link |
|---|---|---|---|
| OCR40493 | Other Identifier | UF OnCore |
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Per study team, the study will not proceed
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| Name | Class |
|---|---|
| Omeros Corporation | INDUSTRY |
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To compare the effect of intraoperative intracameral Omidria (Phenylephrine and Ketorolac 1.0%/0.3%) verses 1% Lidocaine on pain reduction during and after cataract surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Active Comparator | Subjects will receive intracameral 1% preservative-free lidocaine following paracentesis |
|
| Study Experimental Group | Experimental | Subject will receive Omidria (phenylephrine and ketorolac (1.0%/0.3%) added to the ophthalmic irrigating solution during the cataract extraction procedure |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1% preservative-free lidocaine | Drug | Instillation of intracameral lidocaine after initial paracentesis incision. |
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| Measure | Description | Time Frame |
|---|---|---|
| Visual analog scale to measure pain | Measurement of pain intensity by mean visual analog scale (VAS) pain scores from 0 (no pain) to 10 (extreme pain) during operation | Day 1 of operation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Grieser, MD | University of Florida | Principal Investigator |
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| ID | Term |
|---|---|
| D010656 | Phenylephrine |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Phenylephrine 1.0%/ Ketorolac 0.3% | Drug | Instillation of Omidria irrigation solution after paracentesis incision and in irrigation solution. |
|
| D000588 |
| Amines |