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A Comparative Pilot Study Of High-Order Aberrations With Aspheric IOL Models SN60WF and ZCB00

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01105585
First Posted: April 16, 2010
Last Update Posted: November 29, 2012
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):
Alcon Research
  Purpose
The purpose of this study was to prospectively compare high-order aberrations between eyes implanted with the AcrySof® Natural IQ (SN60WF) intraocular lens (IOL) versus those implanted with the Tecnis ZCB00 IOL.

Condition Intervention
Cataracts Device: Tecnis 1-piece Aspheric Acrylic (ZCB00) IOL Device: AcrySof Natural IQ (SN60WF) IOL

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Comparative Pilot Study Of High-Order Aberrations With Aspheric Intraocular Lens (IOL) Models SN60WF And ZCB00

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Total ocular high-order aberrations [ Time Frame: Month 1 postoperative ]

Enrollment: 20
Study Start Date: April 2010
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ZCB00 IOL
Tecnis 1-piece Aspheric Acrylic (ZCB00) intraocular lens (IOL) randomly assigned to one eye, with AcrySof Natural IQ (SN60WF) IOL in the fellow eye for contralateral implantation
Device: Tecnis 1-piece Aspheric Acrylic (ZCB00) IOL
Tecnis 1-piece Aspheric Acrylic (ZCB00) intraocular lens implanted in the capsular bag during cataract surgery. The IOL is intended for the lifetime of the patient.
Active Comparator: SN60WF IOL
AcrySof Natural IQ (SN60WF) intraocular lens (IOL) randomly assigned to one eye, with Tecnis 1-piece Aspheric Acrylic (ZCB00) intraocular lens in the fellow eye for contralateral implantation
Device: AcrySof Natural IQ (SN60WF) IOL
AcrySof Natural IQ (SN60WF) intraocular lens implanted in the capsular bag during cataract surgery. The IOL is intended for the lifetime of the patient.

  Eligibility

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:

  • Requires bilateral extraction of cataracts by phacoemulsification followed by implantation of a posterior chamber intraocular lens;
  • Confirmed absence of pre-existing conditions that could skew the results or present contraindications for the IQ intraocular lens (IOL) or the Tecnis ZCB00 IOL;
  • <1 diopter corneal astigmatism preoperatively;
  • Able to achieve 6.5 mm dilated pupil;
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Chronic disease or illness;
  • Irregular optical aberration;
  • Amblyopia;
  • History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.);
  • Diabetic retinopathy;
  • Macular degeneration;
  • History of retinal detachment;
  • Other surgeries planned at time of cataract removal;
  • Severe dry eye;
  • Other protocol-defined exclusion criteria may apply.
  Contacts and Locations
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): NCT01105585


Locations
United States, Texas
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
  More Information

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01105585     History of Changes
Other Study ID Numbers: M-09-003
First Submitted: April 15, 2010
First Posted: April 16, 2010
Last Update Posted: November 29, 2012
Last Verified: November 2012

Keywords provided by Alcon Research:
Cataracts
aspheric
IOL
ocular aberrations

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases