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The purpose of this multi-center clinical trial is to determine the safety and efficacy of the HSO Toric IOLs for the correction of aphakia and reduction of pre-existing refractive astigmatism.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NHT15 | Experimental | Aspheric Toric Intraocular Lens Models NHT15 |
|
| FY-60AD | Active Comparator | Aspheric Non-toric Intraocular Lens: Model FY-60AD |
|
| NHT30 | Experimental | Aspheric Toric Intraocular Lens Model NHT30 |
|
| NHT53 | Experimental | Aspheric Toric Intraocular Lens Models NHT53 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FY-60AD | Device | Phacoemulsification cataract extraction followed by implantation of an aspheric non-toric intraocular lens: Model FY-60AD. |
|
| Measure | Description | Time Frame |
|---|---|---|
| percent reduction of absolute cylinder | up to 14 months |
| Measure | Description | Time Frame |
|---|---|---|
| Lens rotation or misalignment and patient satisfaction | up to 14 months |
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Inclusion Criteria:
Exclusion Criteria:
Eligibility criteria not complete. Contact Hoya Surgical Optics, Inc. for more information.
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| Name | Affiliation | Role |
|---|---|---|
| Kees den Besten | Hoya Surgical Optics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Contact Hoya Surgical Optics, Inc. for Trial Locations | Chino Hills | California | 91709 | United States | ||
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| ID | Term |
|---|---|
| D001035 | Aphakia |
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| NHT15, NHT30, & NHT53 | Device | Phacoemulsification cataract extraction followed by implantation of an aspheric toric intraocular lens: Model NHT15, NHT30, or NHT53. |
|
| Shepard Eye Center |
| Santa Maria |
| California |
| 93454 |
| United States |
| Mid-Florida Eye Center | Mt. Dora | Florida | 32757 | United States |
| Grosinger, Spigelman & Grey, | Bloomfield Hills | Michigan | 48302 | United States |
| Silverstein Eye Conters | Dansas City | Missouri | 64133 | United States |
| Cleveland Eye Clinic | Brecksville | Ohio | 44141 | United States |