An interventional study of Lenstec Softec HD IOL implantation in Cataract, sponsored by Lenstec Incorporated. Completed. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-03-18.
Sponsored by Lenstec Incorporated · Not applicable, Interventional, and Treatment
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.
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.
1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.
This study's enrollment of 390 is above the median of 80 across 1,155 interventional studies indexed under Cataract.
Browse Cataract studies →Lenstec Incorporated is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
390 eyes of 390 study subjects all receiving the investigational IOL; IOL implanted after surgical removal of cataract
Device: Lenstec Softec HD IOL implantation
surgical removal of cataract and implantation of Softec HD PCIOL
Also known as: Softec HD PCIOL, Softec HD Posterior Chamber IOL, Softec HD Posterior Chamber Intraocular Lens
Distance Best Corrected Visual Acuity
Time frame: 1 year
FDA IOL Grid Adverse Events
Time frame: through 1 year
No study locations are listed for this record.
This study is completed, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.
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Lenstec Incorporated