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This is an observational, follow up study of subjects previously enrolled in the "RxSight Light Adjustable Lens (LAL) and Light Delivery Device (LDD) New Enrollment Study". The primary objective of this study is to collect long-term safety and effectiveness data on RxSight LAL and Control IOL in subjects previously implanted in the "RxSight Light Adjustable Lens (LAL) and Light Delivery Device (LDD) New Enrollment Study".
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Light adjustable lens (LAL) and Light Delivery Device (LDD) | Light adjustable lens (LAL) and Light Delivery Device (LDD) |
| |
| Control IOL | Control IOL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Light Adjustable lens (LAL) and Light Delivery Device (LDD) | Device | Experimental treatment group received Light adjustable lens with Light delivery Device treatments |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean absolute manifest refraction spherical equivalent (|MRSE|) at the Long-Term follow up visit compared between the RxSight LAL and Control group | Up to 55 months | |
| Mean manifest cylinder at the Long-Term follow up visit compared between the RxSight LAL and Control group | Up to 55 months |
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Inclusion Criteria:
Exclusion Criteria:
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The study will include up to 500 subjects who previously participated in the CSP-029 study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Focal Point Vision | San Antonio | Texas | 78229 | United States |
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| Control IOL | Device | Control treatment group received a Control IOL |
|