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Cataract is characterized by the loss of the normal transparency of the crystalline lens. It is a progressive, chronic disease that affect individuals over the age of 50. It is the leading cause of blindness around the world. The EyenableTM IOL (PA60AS1) is a CE-marked foldable single-piece ultra-violet absorbing posterior chamber intraocular lens (IOL). It is an optical implant to replace the human crystalline lens in the visual correction of aphakia in adult patients after cataract removal. This post-market clinical study will investigate the implantation safety and performance of the EyenableTM PA60AS1 intraocular lens (IOL) up to 6 month after the surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EyenableTM PA60AS1 IOL implanation | Other | IOL implantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EyenableTM PA60AS1 IOL | Device | Subjects will undergo surgery to remove cataract (the cloudy lenses) via phacoemulsification, and implant the Eyedeal® EyenableTM PA60AS1 IOL in the eye capsule. |
| Measure | Description | Time Frame |
|---|---|---|
| SAFETY OUTCOME MEASURE - Adverse event | The primary safety endpoints include rates of adverse events, loss of CDVA, slit lamp examination, fundus examination, intraocular pressure, device deficiencies. | 6 month after the device implantation. |
| PERFORMANCE OUTCOME MEASURE - uncorrected distance visual acuity (UCDVA) | Measurement of UCDVA | 6 month after the device implantation |
| PERFORMANCE OUTCOME MEASURE - Corrected distance visual acuity (CDVA) | Measurement of CDVA | 6 month after the device implantation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Q. Trin Peng, MD | Contact | +86 029 848 88888 | info@eyedeal.com |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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