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The purpose of the following clinical protocol is to evaluate the safety and effectiveness of the Lenstec Tetraflex Accommodating Posterior Chamber Intraocular Lens (IOL) for the protocol inclusion/exclusion criteria.
The Lenstec TetraFlex Accommodating Posterior Chamber Intraocular Lens (IOL) is an ultraviolet absorbing optical implant designed for the replacement of the human crystalline lens following phacoemulsification cataract removal. The TetraFlex Accommodating Posterior Chamber IOL is designed for treatment of aphakia. The lens is indicated for primary implantation when a cataractous lens has been removed by phacoemulsification with circular tear capsulotomy and the posterior capsule intact. The intended benefit of the TetraFlex Accommodating Posterior Chamber IOL is to provide enhanced distance and near vision with an increased independence from corrective lens wear.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lenstec Tetraflex IOL implantation | Experimental | patients in Study arm received TetraFlex Lens |
|
| Control IOL | Active Comparator | commercially approved PCIOL implanted |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| posterior chamber IOL implantation | Device |
| ||
| Experimental TetraFlex Study IOL |
| Measure | Description | Time Frame |
|---|---|---|
| The primary efficacy outcome is the assessment of the % of eyes obtaining 20/40 or better distance best corrected visual acuity. | 1 year | |
| The primary safety outcome is the incidence/severity of adverse events and complications. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Patient's functional reading ability, and other distance, near and intermediate vision testing including subjective patient survey outcomes on dependence on corrective eyewear and patient symptoms. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Donald R Sanders, MD, PhD | Center for Clinical Research | Study Director |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| Device |
TetraFlex IOL implanted |
|