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The purpose of this study is to understand the visual outcomes of the investigational intraocular lens (IOL) Model LPYWT0 when compared to the commercially marketed Clareon PanOptix Pro IOL Model PXYWT0.
In this study, subjects with cataracts in both eyes will undergo cataract surgery and be implanted with trifocal IOLs. One eye will receive the investigational IOL Model LPYWT0 IOL, and the other eye will receive the commercially marketed Clareon PanOptix Pro IOL Model PXYWT0. The second eye surgery will occur 7-14 days after the first. Subjects will attend 9 planned study visits to include for an individual duration of participation of approximately 7 months.
This study is planned to be conducted in India and the Philippines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LPYWT0 / PXYWT0 | Other | Investigational IOL Model LPYWT0 implanted in the first operative eye during cataract surgery with Clareon PanOptix Pro IOL Model PXYWT0 in the second eye, as randomized. The second eye will be implanted 7-14 days after the first. |
|
| PXYWT0 / LPYWT0 | Other | Clareon PanOptix Pro IOL Model PXYWT0 implanted in the first operative eye during cataract surgery with investigational IOL Model LPYWT0 implanted in the second eye, as randomized. The second eye will be implanted 7-14 days after the first. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LPYWT0 | Device | Investigational blue light filtering trifocal IOL implanted in the capsular bag of the eye during cataract surgery intended to remain in the eye for the lifetime of the subject. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA) | Visual Acuity will be assessed using letter charts under well-lit (photopic) conditions with correction in place at a distance of 4 meters from the subject. BCDVA will be recorded in logarithm minimum angle of resolution (logMAR) where 0.0 logMAR is equivalent to 20/20 Snellen, or normal distance eyesight, and negative logMAR values represent better-than-normal distance eyesight. | Month 6 postoperative |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alcon Call Center | Contact | 1-888-451-3937 | alcon.medinf@alcon.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Lead, Surgical | Alcon Research, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Agarwal's Eye Hospital Limited | Chennai | Tamil Nadu | 600018 | India | ||
| Narayana Nethralaya |
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| Label | URL |
|---|---|
| Educational | View source |
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| ID | Term |
|---|---|
| D001035 | Aphakia |
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D002387 | Cataract Extraction |
| ID | Term |
|---|---|
| D054140 | Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| PXYWT0 | Device | Commercially available blue light filtering trifocal IOL implanted in the capsular bag of the eye during cataract surgery intended to remain in the eye for the lifetime of the subject. |
|
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| Cataract Surgery | Procedure | Removal of the cataractous lens by phacoemulsification followed by implantation of the IOL |
|
| Bangalore |
| 560010 |
| India |
| Peregrine Eye Laser and Institute | Makati City | Manila | 1209 | Philippines |
| Asian Eye Institute | Makati City | 1200 | Philippines |