Lenstec Softec HD Posterior Chamber Intraocular Lens Clinical Investigational Protocol
Not Applicable
Completed
- Conditions
- Cataract
- Interventions
- Device: Lenstec Softec HD IOL implantation
- Registration Number
- NCT00963742
- Lead Sponsor
- Lenstec Incorporated
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 390
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Lenstec Softec HD IOL implantation Lenstec Softec HD IOL implantation 390 eyes of 390 study subjects all receiving the investigational IOL; IOL implanted after surgical removal of cataract
- Primary Outcome Measures
Name Time Method Distance Best Corrected Visual Acuity 1 year
- Secondary Outcome Measures
Name Time Method FDA IOL Grid Adverse Events through 1 year