Lenstec Softec HD Posterior Chamber Intraocular Lens Clinical Investigational Protocol

Lenstec

Status: Completed

Conditions: Cataract

Treatments: Device: Lenstec Softec HD IOL implantation

Study type: Interventional

Funder types: Industry

Identifiers

NCT00963742

IDE G060058

Details and patient eligibility

About

The objectives of this multi-center clinical investigation are to determine the safety and effectiveness of the Lenstec Softec HD Posterior Chamber intraocular lens (IOL) following one year of post-operative assessment.

Full description

The Softec HD Posterior Chamber IOL is designed for the 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 Softec HD Posterior Chamber IOL is to provide enhanced vision.

Enrollment: 390 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Cataract requiring cataract extraction
• Study IOL to only be implanted in 1 eye
• Distance BCVA 20/40 or worse or glare acuity worse than 20/30
• Ability to comply with study follow-up requirements

Exclusion criteria

• Patients with serious corneal disease, previous surgery or serious systemic disease
• Ocular condition that could impact vision after cataract surgery
• Pregnant or lactating women
• Use of ocular or systemic medications that could impact vision

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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390 participants in 1 patient group

Lenstec Softec HD IOL implantation

Experimental group

Description:

390 eyes of 390 study subjects all receiving the investigational IOL; IOL implanted after surgical removal of cataract

Treatment:

Device: Lenstec Softec HD IOL implantation