Text Size

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

This study is currently recruiting participants.
Verified June 2011 by Lenstec Incorporated
Sponsor:
Information provided by:
Lenstec Incorporated
ClinicalTrials.gov Identifier:
NCT01249144
First received: November 24, 2010
Last updated: June 27, 2011
Last verified: June 2011
History of Changes

November 24, 2010
June 27, 2011
October 2010
January 2012   (final data collection date for primary outcome measure)
Target versus Achieved Refraction [ Time Frame: 3 Months Postoperative ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01249144 on ClinicalTrials.gov Archive Site
Uncorrected Visual Acuity [ Time Frame: 3 Months Postoperative ] [ Designated as safety issue: No ]
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 Blind (Subject, 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.
 
Recruiting
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
Both
21 Years and older
No
Contact: J. Pitzer Gills, III, MD 800.282.9905
United States
 
NCT01249144
LTHD-10-05
No
Erin Hayes / Director of Clinical Research, Lenstec, Inc.
Lenstec Incorporated
Not Provided
Principal Investigator: J. Pitzer Gills, III, MD St. Luke's Cataract and Laser Institute
Lenstec Incorporated
June 2011

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