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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Lenstec Incorporated
ClinicalTrials.gov Identifier:
NCT01249144
First received: November 24, 2010
Last updated: March 17, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Cataract
Device: Intraocular Lens (IOL)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Lenstec Incorporated:

Primary Outcome Measures:
  • Target versus Achieved Refraction [ Time Frame: 3 Months Postoperative ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Uncorrected Visual Acuity [ Time Frame: 3 Months Postoperative ] [ Designated as safety issue: No ]

Enrollment: 75
Study Start Date: October 2010
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Tecnis Z9002 Intraocular Lens (IOL) Device: Intraocular Lens (IOL)
Device for implantation in the capsular bag of the eye for visual correction of aphakia following cataract surgery.
Active Comparator: Softec HD Intraocular Lens (IOL) Device: Intraocular Lens (IOL)
Device for implantation in the capsular bag of the eye for visual correction of aphakia following cataract surgery.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01249144

Locations
United States, Florida
St. Luke's Cataract & Laser Institute
Tarpon Springs, Florida, United States, 34689
Sponsors and Collaborators
Lenstec Incorporated
Investigators
Principal Investigator: J. Pitzer Gills, III, MD St. Luke's Cataract and Laser Institute
  More Information

No publications provided

Responsible Party: Lenstec Incorporated
ClinicalTrials.gov Identifier: NCT01249144     History of Changes
Other Study ID Numbers: LTHD-10-05
Study First Received: November 24, 2010
Last Updated: March 17, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Lenstec Incorporated:
Intraocular Lens (IOL)
Quarter Diopter
Biaspheric

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on April 16, 2014