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Lenstec Softec HD Posterior Chamber Intraocular Lens Clinical Investigational Protocol

This study has been completed.
Sponsor:
Information provided by:
Lenstec Incorporated
ClinicalTrials.gov Identifier:
NCT00963742
First received: August 20, 2009
Last updated: June 27, 2011
Last verified: August 2009
History of Changes

August 20, 2009
June 27, 2011
December 2006
July 2009   (final data collection date for primary outcome measure)
Distance Best Corrected Visual Acuity [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00963742 on ClinicalTrials.gov Archive Site
FDA IOL Grid Adverse Events [ Time Frame: through 1 year ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Lenstec Softec HD Posterior Chamber Intraocular Lens Clinical Investigational Protocol
Lenstec Softec HD Posterior Chamber Intraocular Lens (PCIOL) Clinical Investigational Protocol

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.
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Cataract
Device: Lenstec Softec HD Posterior Chamber Intraocular Lens
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
Experimental: IOL implantation
390 eyes of 390 study subjects all receiving the investigational IOL; IOL implanted after surgical removal of cataract
Intervention: Device: Lenstec Softec HD Posterior Chamber Intraocular Lens
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
390
April 2010
July 2009   (final data collection date for primary outcome measure)

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
Both
21 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00963742
IDE G060058
No
Jimmy Chacko/Vice President of Regulatory Affairs, Lenstec Incorporated
Lenstec Incorporated
Not Provided
Study Director: Donald R Sanders, M.D. Ph.D Center for Clinical Research
Lenstec Incorporated
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP