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The purpose of this study is to evaluate the safety and performance of the SBL-3 intraocular lens.
The purpose of this study is to evaluate the safety (adverse events) and performance (visual acuity, spectacle independence) of the SBL-3 intraocular lens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SBL-3 multifocal intraocular lens | Experimental | The SBL-3 intraocular lens will be implanted after the cataractous natural lens has been removed, in those patients randomized into this group |
|
| Control monofocal intraocular lens | Active Comparator | The Control intraocular lens will be implanted after the cataractous natural lens has been removed, in those patients randomized into this group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SBL-3 multifocal intraocular lens | Device | The SBL-3 intraocular lens will be implanted after the cataractous natural lens has been removed, in those patients randomized into this group |
| Measure | Description | Time Frame |
|---|---|---|
| photopic, distance corrected, monocular near visual acuity | a measure of near vision | 1 year following implantation |
| presence or absence of adverse events | presence or absence of adverse events | 1 year following implantation |
| photopic, distance corrected, monocular intermediate visual acuity | a measure of intermediate vision | 1 year following implantation |
| photopic, best corrected, monocular distance visual acuity | a measure of distance vision | 1 year following implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects who are independent of spectacles | a measure of the independence from spectacles | 1 year following implantation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Blake Harris | Lenstec Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye Center South | Dothan | Alabama | 36301 | United States | ||
| Shepard Eye Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41385130 | Derived | Shields AL, Galipeau N, Litcher-Kelly L, Moreno-Koehler A, Chacko J. The patient reported intraocular lens questionnaire (PR-ILQ): content validity, psychometric performance, and use in a regulated clinical trial to evaluate safety and effectiveness outcomes. J Patient Rep Outcomes. 2025 Dec 12;9(1):142. doi: 10.1186/s41687-025-00968-0. |
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SBL-3 multifocal intraocular lens
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| Control monofocal intraocular lens | Device | The Control intraocular lens will be implanted after the cataractous natural lens has been removed, in those patients randomized into this group |
|
| Santa Maria |
| California |
| 93454 |
| United States |
| Cape Coral Eye Center | Cape Coral | Florida | 33904 | United States |
| Eye Centers of Florida | Fort Myers | Florida | 33901 | United States |
| Newsom Eye & Laser Center | Sebring | Florida | 33870 | United States |
| Family Eye Centers | Willmar | Minnesota | 56201 | United States |
| The Eye Center of Central PA | Allenwood | Pennsylvania | 17810 | United States |
| Eye Care Specialists | Kingston | Pennsylvania | 18704 | United States |
| Carolina Eyecare Physicians | Mt. Pleasant | South Carolina | 29464 | United States |
| Loden Vision Center | Goodlettsville | Tennessee | 37072 | United States |
| Kleiman/Evangelista Eye Center | Arlington | Texas | 76018 | United States |
| Whitsett Vision Group | Houston | Texas | 77055 | United States |
| The Eye Institute of Utah | Salt Lake City | Utah | 84107 | United States |
| ID | Term |
|---|---|
| D002386 | Cataract |
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D012030 | Refractive Errors |
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