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This is a two-part, multi-center, investigator-initiated clinical study comparing visual outcomes and patient satisfaction in subjects receiving bilateral implantation of either the Clareon PanOptix intraocular lens (IOL) or a comparable multifocal IOL. The study includes a retrospective/prospective pilot phase and a prospective, randomized comparison phase.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clareon PanOptix or PanOptix Toric IOLs | Experimental |
| |
| Comparable multifocal IOL | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clareon PanOptix or PanOptix Toric IOLs | Device | Bilateral implantation of the Clareon PanOptix or PanOptix Toric IOLs. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Binocular photopic BCDVA (4m) | 2.5 to 5 months postoperatively | |
| Binocular BCDVA (4m) | Month 3 |
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Inclusion Criteria:
Stage 1: IIT Pilot
Stage 2: Comparison
Exclusion Criteria:
Stage 1: IIT Pilot
Stage 2: Comparison
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wolstan & Goldberg Eye Associates | Recruiting | Torrance | California | 90505 | United States |
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| Comparable multifocal IOL | Device | Bilateral implantation of a comparable multifocal IOL |
|
| Tyson Eye | Recruiting | Cape Coral | Florida | 33904 | United States |
|
| North Georgia Eye Associates | Recruiting | Gainesville | Georgia | 30501 | United States |
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