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Phase 1 will be ambispective, multi-site, single arm study in age-related cataract patients with regular astigmatism, who were bilaterally treated with the LAL+ IOLs
Phase 2 will be a prospective, randomized, unmasked, comparative, multi-site study with 90 days of follow up. Subjects will be randomized in a 1:1 manner to LAL+ or Clareon VIvity Toric IOLs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LAL+ | Experimental |
| |
| Clareon Vivity Toric IOLs | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LAL+ | Device | LAL+ IOL allows for refractive error (both sphere and cylinder) enhancements post-IOL implantation by exposing the IOL to ultraviolet (UV) light through a series of noninvasive treatments with a Light Delivery Device. |
| Measure | Description | Time Frame |
|---|---|---|
| Binocular photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 cm | Binocular photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 cm | at the 90-day post-op visit or at least 1 week after final lock-in if longer than 3 months for LAL+ implanted subjects and >2 weeks post YAG, if done. |
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Inclusion Criteria:
Exclusion Criteria:
Moderate-severe corneal pathology;
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cathleen McCabe, MD | Contact | 941-220-5987 | cmccabe13@hotmail.com | |
| Alisha Polson | Contact | 941-220-5987 |
| Name | Affiliation | Role |
|---|---|---|
| Cathleen M McCabe, MD | The Eye Associates of Manatee | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Eye Associates of Manatee, LLP | Bradenton | Florida | 34209 | United States |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| Clareon Vivity Toric IOL | Device | Clareon Vivity Toric IOL utilizes an extended depth of focus (EDOF) design, which incorporates nondiffractive wavefront shaping (X-WAVE) technology. |
|