Cataract
Conditions
Keywords
cataract surgery, IOL, Intraocular lens
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.
Interventions
DEVICELenstec Softec HD IOL implantation
surgical removal of cataract and implantation of Softec HD PCIOL
Sponsors
Lenstec Incorporated
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Distance Best Corrected Visual Acuity | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| FDA IOL Grid Adverse Events | through 1 year |
Outcome results
None listed