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Lenstec Softec HD Posterior Chamber Intraocular Lens Clinical Investigational Protocol

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ClinicalTrials.gov Identifier: NCT00963742
Recruitment Status : Completed
First Posted : August 21, 2009
Last Update Posted : March 18, 2014
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Cataract Device: Lenstec Softec HD IOL implantation Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 390 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Lenstec Softec HD Posterior Chamber Intraocular Lens (PCIOL) Clinical Investigational Protocol
Study Start Date : December 2006
Actual Primary Completion Date : July 2009
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Lenstec Softec HD IOL implantation
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
Other Names:
  • Softec HD PCIOL
  • Softec HD Posterior Chamber IOL
  • Softec HD Posterior Chamber Intraocular Lens



Primary Outcome Measures :
  1. Distance Best Corrected Visual Acuity [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. FDA IOL Grid Adverse Events [ Time Frame: through 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00963742


Sponsors and Collaborators
Lenstec Incorporated
Investigators
Study Director: Donald R Sanders, M.D. Ph.D Center for Clinical Research

Responsible Party: Lenstec Incorporated
ClinicalTrials.gov Identifier: NCT00963742     History of Changes
Other Study ID Numbers: IDE G060058
First Posted: August 21, 2009    Key Record Dates
Last Update Posted: March 18, 2014
Last Verified: March 2014

Keywords provided by Lenstec Incorporated:
cataract surgery
IOL
Intraocular lens

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases