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

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ClinicalTrials.gov Identifier: NCT01249144
Recruitment Status : Terminated
First Posted : November 29, 2010
Last Update Posted : March 18, 2014
Sponsor:
Information provided by (Responsible Party):
Lenstec Incorporated

Brief Summary:
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 or disease Intervention/treatment Phase
Cataract Device: Intraocular Lens (IOL) Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : October 2010
Primary Completion Date : January 2012
Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract
U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Target versus Achieved Refraction [ Time Frame: 3 Months Postoperative ]

Secondary Outcome Measures :
  1. Uncorrected Visual Acuity [ Time Frame: 3 Months Postoperative ]


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:   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

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): 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

Responsible Party: Lenstec Incorporated
ClinicalTrials.gov Identifier: NCT01249144     History of Changes
Other Study ID Numbers: LTHD-10-05
First Posted: November 29, 2010    Key Record Dates
Last Update Posted: March 18, 2014
Last Verified: March 2014

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

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases