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Sponsor did not recruit enough subjects to file PMA.
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To evaluate the Model SC9 Intraocular Lens for the improvement of near and intermediate vision when compared to a legally marketed monofocal IOL.
Subjects will be randomized to one of two groups. Group A, (Test Lens, Model SC9) or Group B, (Control Lens, Model LI61SE, Bausch and Lomb).
Both groups will be randomized to receive either unilateral or bilateral implantation. No bilateral implantation is allowed in Phase 1. (50 subjects).
Subjects will be followed for 36 Months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Model SC9 | Experimental | Investigational IOL |
|
| Model LI61SE | Active Comparator | FDA Approved IOL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Model SC9 | Device | Experimental |
| |
| Model LI61SE |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in Visual Acuity Measurements using the LogMar Scale | Subjects must read 20/40 or better, distance corrected near visual acuity and 20/40 or better distance corrected intermediate visual acuity. This is achieved with the subject wearing their best corrected spectacle correction in place and reading a series of letters at 40cm/16" and 80cm/32". Total letters read for each line will determine their visual acuity | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Defocus testing in 0.5D increments from -0.5 to -5.00D | A sub-set of 50 subjects will undergo defocus testing with their best distance correction in place. Minus Lenses in 0.5D increments will be placed over their best spectacle correction. Total letters read for each diopter will be recorded. Percentage of eyes with improvement of monocular depth of focus by at least 0.5D mean difference between the Model SC9 and control lens.(significance level of 0.025). To demonstrate superiority of at least 0.5D compared to the control lens >75% of eyes implanted with the Model SC9 should demonstrate superiority by at least 0.5D mean difference compared to the control lens. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Hovanesian, M.D. | CORD, LLC | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Davies Eye Center | Carlsbad | California | 92008 | United States | ||
| Harvard Eye Associates |
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Enrolled subjects will not be told which IOL they have received until the end of the study
| Device |
Active Comparator |
|
| 12 Months |
| Laguna Hills |
| California |
| 92653 |
| United States |
| Coastal Vision Laser Eye Center | Orange | California | 92868 | United States |
| Shasta Eye Medical Group, Inc. | Redding | California | 96001 | United States |
| Aker-Kasten Eye Center | Boca Raton | Florida | 33432 | United States |
| The Eye Institute of West Florida | Largo | Florida | 33770 | United States |
| Chu Vision Institute | Bloomington | Minnesota | 55420 | United States |
| Silverstein Eye Centers | Kansas City | Missouri | 64133 | United States |
| Center for Sight | Las Vegas | Nevada | 89145 | United States |
| Fine, Hoffman and Sims | Eugene | Oregon | 97401 | United States |
| Houston Eye Associates | Houston | Texas | 77008 | United States |
| Parkhurst NuVision | San Antonio | Texas | 78229 | United States |
| Eye Associates of South Texas | San Antonio | Texas | 78247 | United States |
| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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