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The purpose of this study is to evaluate the clinical outcomes of an investigational IOL in patients undergoing cataract extraction and intraocular lens implantation using an improved injector system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FluidVision | Experimental | FluidVision AIOL implanted in the capsular bag of the eye during cataract surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FluidVision AIOL | Device | Investigational implantable medical device intended for long-term use over the lifetime of the cataract subject. An improved injector system was used. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Accommodative amplitude | Accommodative amplitude is a measure of the ability of the eye to focus from a target that is at distance into a target that is near. | Month 6 |
| Best corrected distance visual acuity (BCDVA) | Visual acuity of the eye will be tested with the correction in place. | Month 6 |
| Rates of adverse events | Adverse events will be collected from time of enrollment to study exit. | Up to Month 36 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PowerVision Investigative Site | Budapest | Hungary | ||||
| PowerVision Investigative Site |
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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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| Cataract surgery | Procedure | Performed using standard microsurgical techniques |
|
| Claremont |
| Cape Town |
| 2001 |
| South Africa |
| PowerVision Investigative Site | Northcliff | Johannesburg | 2001 | South Africa |
| PowerVision Investigative Site | Queenswood | Pretoria | 2001 | South Africa |
| PowerVision Investigative Site | Somerset West | South Africa |