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The purpose of this post-market study is to describe the long-term safety and performance of Clareon Toric Intraocular Lenses (IOLs).
Subjects will attend up to 12 scheduled visits (one preoperative visit, up to two surgical visits, and up to 9 postoperative visits) over the course of the study (3 years follow-up). The overall study duration is expected to be approximately 4 years. This study will be conducted in Canada.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clareon Toric IOL | Experimental | Clareon Toric IOL implanted in one or both eyes during cataract surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clareon Toric IOL | Device | Aspheric hydrophobic acrylic IOL placed in the capsular bag in the posterior chamber of the eye during cataract surgery for the visual correction of aphakia and preexisting corneal astigmatism |
| Measure | Description | Time Frame |
|---|---|---|
| Mean monocular best corrected distance visual acuity (BCDVA) | Visual acuity will be assessed for each eye individually using letter charts and recorded in logarithm minimum angle of resolution (logMAR). | Month 6, Year 1, Year 3 (post implantation) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean monocular absolute residual refractive cylinder | The amount of residual astigmatism will be assessed for each eye individually using letter charts and recorded in diopters. | Month 3, Month 6, Year 1, Year 3 (post implantation) |
| Mean absolute IOL rotation from previous visit |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management Operations, Surgical | Alcon Research, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gimbel Eye Centre | Calgary | Alberta | T3B 0M3 | Canada | ||
| Uptown Eye Specialists |
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| ID | Term |
|---|---|
| D001035 | Aphakia |
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D012030 | Refractive Errors |
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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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|
| Cataract surgery | Procedure | Cataract extraction by phacoemulsification, followed by implantation with a Clareon Toric IOL |
|
The difference in IOL axis of orientation from the previous visit will be assessed by a reading center and recorded in degrees. |
| Month 1 to Month 3, Month 3 to Month 6, Month 6 to Year 1, Year 1 to Year 3 (post implantation) |
| Mean absolute IOL rotation from end of surgery supine baseline to each subsequent visit | The difference in IOL axis of orientation from baseline (end of surgery, patient laying flat) will be assessed by a reading center and recorded in degrees. | Baseline, Day 1, Week 1, Month 1, Month 3, Month 6, Year 1, Year 3 (post implantation) |
| Concord |
| Ontario |
| L4K 2Z5 |
| Canada |
| Prism Eye Institute | Oakville | Ontario | L6H 0J8 | Canada |
| Laurentians Eye Institute | Boisbriand | Quebec | J7H 0E8 | Canada |
| Bellevue | Montreal | Quebec | H1V 1G5 | Canada |
| McGill University | Montreal | Quebec | R7A 3N2 | Canada |