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A study to evaluate the real-world clinical performance of the enVista Aspire and Aspire Toric intraocular lens (IOL) models EA and ETA and to assess surgeon and subject satisfaction
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects bilaterally implanted with enVista Aspire EA or Aspire Toric ETA IOLs | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| enVista Aspire EA or Aspire Toric ETA IOLs | Device | enVista Aspire EA or Aspire Toric ETA IOLs |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean binocular best-corrected distance visual acuity (BCDVA) at Postoperative Visit 1 | Mean binocular best-corrected distance visual acuity (BCDVA) at Postoperative Visit 1 | Assessed at Postop visit 1 (Day 14 to 42 days after second eye IOL implantation) |
| Percentage of subjects with binocular BCDVA of 20/40 or better at Postoperative Visit 1 | Percentage of subjects with binocular BCDVA of 20/40 or better at Postoperative Visit 1 | Assessed at Postop visit 1 (Day 14 to 42 days after second eye IOL implantation) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 118 | Birmingham | Alabama | 35209 | United States | ||
| Site 154 |
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| Bullhead City |
| Arizona |
| 86442 |
| United States |
| Site 137 | Chandler | Arizona | 85224 | United States |
| Site 136 | Mesa | Arizona | 85202 | United States |
| Site 162 | Phoenix | Arizona | 85028 | United States |
| Site 105 | Tucson | Arizona | 85704 | United States |
| Site 104 | Bakersfield | California | 93309 | United States |
| Site 101 | Beverly Hills | California | 90210 | United States |
| Site 151 | Hemet | California | 92543 | United States |
| Site 111 | Huntington Beach | California | 92647 | United States |
| Site 126 | Long Beach | California | 90805 | United States |
| Site 149 | Los Angeles | California | 90024 | United States |
| Site 155 | Murrieta | California | 92562 | United States |
| Site 109 | Newport Beach | California | 92707 | United States |
| Site 112 | Orange | California | 92868 | United States |
| Site 144 | Pasadena | California | 91107 | United States |
| Site 119 | Torrance | California | 90505 | United States |
| Site 115 | Upland | California | 91786 | United States |
| Site 161 | Greenwich | Connecticut | 06830 | United States |
| Site 130 | Milford | Connecticut | 06460 | United States |
| Site 164 | Stamford | Connecticut | 06902 | United States |
| Site 125 | Bradenton | Florida | 34209 | United States |
| Site 148 | Mt. Dora | Florida | 32757 | United States |
| Site 143 | Pompano Beach | Florida | 33064 | United States |
| Site 127 | Tarpon Springs | Florida | 34689 | United States |
| Site 153 | Winter Park | Florida | 32792 | United States |
| Site134 | Gainesville | Georgia | 30501 | United States |
| Site 165 | Roswell | Georgia | 30076 | United States |
| Site 163 | Honolulu | Hawaii | 96813 | United States |
| Site 160 | Honolulu | Hawaii | 96814 | United States |
| Site 108 | Rock Island | Illinois | 61201 | United States |
| Site 133 | Shreveport | Louisiana | 71103 | United States |
| Site 131 | Birmingham | Michigan | 48009 | United States |
| Site 121 | Alexandria | Minnesota | 56308 | United States |
| Site 142 | Alexandria | Minnesota | 56308 | United States |
| Site 102 | Bloomington | Minnesota | 55420 | United States |
| Site 106 | Kansas City | Missouri | 64133 | United States |
| Site 128 | Bozeman | Montana | 59718 | United States |
| Site 117 | South Sioux City | Nebraska | 68776 | United States |
| Site 114 | South Orange | New Jersey | 07079 | United States |
| Site 159 | Albuquerque | New Mexico | 87109 | United States |
| Site132 | Poughkeepsie | New York | 12603 | United States |
| Site 138 | Goldsboro | North Carolina | 27534 | United States |
| Site 156 | Leland | North Carolina | 28451 | United States |
| Site 107 | West Fargo | North Dakota | 58078 | United States |
| Site 103 | Brecksville | Ohio | 44142 | United States |
| Site 129 | Cincinnati | Ohio | 45242 | United States |
| Site 166 | Moore | Oklahoma | 73160 | United States |
| Site 152 | Bend | Oregon | 97701 | United States |
| Site 135 | Medford | Oregon | 97504 | United States |
| Site 150 | Allenwood | Pennsylvania | 17810 | United States |
| Site 140 | Bala-Cynwyd | Pennsylvania | 19004 | United States |
| Site 157 | Kingston | Pennsylvania | 18704 | United States |
| Site 145 | Austin | Texas | 78704 | United States |
| Site 158 | Austin | Texas | 78731 | United States |
| Site 113 | Beaumont | Texas | 77707 | United States |
| Site 110 | Dallas | Texas | 75243 | United States |
| Site 147 | Houston | Texas | 77008 | United States |
| Site 141 | Houston | Texas | 77055 | United States |
| Site 123 | San Antonio | Texas | 78209 | United States |
| Site 124 | San Antonio | Texas | 78229 | United States |
| Site 122 | Salt Lake City | Utah | 84107 | United States |
| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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