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The purpose of this study is to determine whether Vitrase (hyaluronidase for injection) is effective as a spreading agent for other injected drugs prior to ocular surgery
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitrase | Experimental | ovine hyaluronidase injection 150 USP Units in 1 mL solution. Single dose of Vitrase will be administered as an adjuvant prior to ophthalmologic surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitrase | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Physician Satisfaction Survey | Physician evaluation of effectiveness of Vitrase as an adjuvant and overall satisfaction, via questionnaire; | 1-2 days |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | occurrence, severity, relationship, duration, resolution, and seriousness of adverse events | 1-2 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa R Grillone, PhD | ISTA Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| David Wirta, MD, Inc. | Newport Beach | California | 92663 | United States | ||
| Richard A Lewis, MD |
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| Sacramento |
| California |
| 95815 |
| United States |
| E Randy Craven, MD | Littleton | Colorado | 80120 | United States |
| The Eye Care Group | New Haven | Connecticut | 06510 | United States |
| Advanced Eye Care, PC | Fort Oglethorpe | Georgia | 30742 | United States |
| Donald E Beahm, MD | Great Bend | Kansas | 67530 | United States |
| Cincinnati Eye Institute NKY | Edgewood | Kentucky | 41017 | United States |
| Cornea Consultants | Boston | Massachusetts | 02114 | United States |
| Hunkeler Eye Institute | Kansas City | Missouri | 64111 | United States |
| Ophthalmic Consultants of Long Island | Rockville Centre | New York | 11570 | United States |
| David L Schwartz, MD | Tulsa | Oklahoma | 74104 | United States |
| Black Hills Regional Eye Institute | Rapid City | South Dakota | 57701 | United States |
| Texan Eye Care PA | Austin | Texas | 78705 | United States |
| Ophthalmology Service, Brooke Army Medical Center | Fort Sam Houston | Texas | 78234 | United States |
| Ophthalmology Visual Science | Galveston | Texas | 77555 | United States |
| Houston Eye Associates | Houston | Texas | 77025 | United States |
| David G Shulman, MD | San Antonio | Texas | 78209 | United States |
| Central Texas Eye Center | San Marcos | Texas | 78666 | United States |
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002810 | Chondroitinases and Chondroitin Lyases |
| ID | Term |
|---|---|
| D013429 | Sulfatases |
| D004950 | Esterases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D011133 | Polysaccharide-Lyases |
| D019757 | Carbon-Oxygen Lyases |
| D008190 | Lyases |
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