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Visual and Refractive Outcomes After Implantation of Aspheric IOLs With Different Dioptric Increments and Manufacturing

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01249144
First Posted: November 29, 2010
Last Update Posted: March 18, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Lenstec Incorporated
November 24, 2010
November 29, 2010
March 18, 2014
October 2010
January 2012   (Final data collection date for primary outcome measure)
Target versus Achieved Refraction [ Time Frame: 3 Months Postoperative ]
Same as current
Complete list of historical versions of study NCT01249144 on ClinicalTrials.gov Archive Site
Uncorrected Visual Acuity [ Time Frame: 3 Months Postoperative ]
Same as current
Not Provided
Not Provided
 
Visual and Refractive Outcomes After Implantation of Aspheric IOLs With Different Dioptric Increments and Manufacturing
A Randomized Fellow-eye Controlled Clinical Trial to Compare the Visual and Refractive Outcomes Between Two Aspheric IOLs With Different Dioptric Increments and Manufacturing Tolerances in Patients Undergoing Bilateral Cataract Surgery
This study compares two intraocular lenses, the Softec HD and the Tecnis Z9002, used to replace the natural crystalline lens after cataract extraction. The variables compared include 1) the accuracy of targeted versus achieved refractive outcomes and 2) visual acuity outcomes three months after implantation.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Cataract
Device: Intraocular Lens (IOL)
Device for implantation in the capsular bag of the eye for visual correction of aphakia following cataract surgery.
  • Active Comparator: Tecnis Z9002 Intraocular Lens (IOL)
    Intervention: Device: Intraocular Lens (IOL)
  • Active Comparator: Softec HD Intraocular Lens (IOL)
    Intervention: Device: Intraocular Lens (IOL)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
75
January 2012
January 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • operable cataracts in both eyes
  • require intraocular lenses (IOLs) in dioptric range from 18.0 diopters to 25.0 diopters in both eyes
  • </=1 diopter (D) of regular astigmatism in both eyes

Exclusion Criteria:

  • Intraocular surgery or laser treatment prior to cataract surgery
  • Severe dry eye
  • Presence of ocular infection
  • Uncontrolled intraocular pressure (IOP) or glaucoma preventing a postoperative best corrected visual acuity (BCVA) of 20/25 Snellen or better
  • Retinal or macular pathology preventing a postoperative BCVA of 20/25 Snellen or better
  • History of retinal detachment
  • Corneal decompensation
  • History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.)
  • Clinically significant corneal endothelial dystrophy (e.g., Fuchs' dystrophy)
  • Amblyopia preventing a postoperative BCVA of 20/25 Snellen or better
Sexes Eligible for Study: All
21 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01249144
LTHD-10-05
No
Not Provided
Not Provided
Lenstec Incorporated
Lenstec Incorporated
Not Provided
Principal Investigator: J. Pitzer Gills, III, MD St. Luke's Cataract and Laser Institute
Lenstec Incorporated
March 2014

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