NCT00969371

Lenstec Tetraflex Accommodating Posterior Chamber Intraocular Lens (IOL) Clinical Investigation

Lenstec TetraFlex Accommodating Posterior Chamber Intraocular Lens (IOL)Clinical Investigation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 470 (actual)
• Sponsor: Lenstec Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Cataract

Interventions

Type	Name	Description
DEVICE	posterior chamber IOL implantation
DEVICE	Experimental TetraFlex Study IOL	TetraFlex IOL implanted

Timeline

• Start date: 2005-09-01
• Primary completion: 2009-06-01
• Completion: 2009-06-01
• First posted: 2009-09-01
• Last updated: 2018-10-18