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Sponsor stopped study to re-design trial
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This study compares two intraocular lenses, the Softec HD and the Tecnis Z9002, used to replace the natural crystalline lens after cataract extraction. The variables compared include 1) the accuracy of targeted versus achieved refractive outcomes and 2) visual acuity outcomes three months after implantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tecnis Z9002 Intraocular Lens (IOL) | Active Comparator |
| |
| Softec HD Intraocular Lens (IOL) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intraocular Lens (IOL) | Device | Device for implantation in the capsular bag of the eye for visual correction of aphakia following cataract surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Target versus Achieved Refraction | 3 Months Postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Uncorrected Visual Acuity | 3 Months Postoperative |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| J. Pitzer Gills, III, MD | St. Luke's Cataract and Laser Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Luke's Cataract & Laser Institute | Tarpon Springs | Florida | 34689 | United States |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D007910 | Lenses, Intraocular |
| ID | Term |
|---|---|
| D007909 | Lenses |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D019736 | Prostheses and Implants |
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