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Completed

NCT Number: NCT01105585

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

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.

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Key information

Conditions

Cataracts Cataract Eye Diseases Lens Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, 76134, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tecnis 1-piece Aspheric Acrylic (ZCB00) IOL

Device

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.

AcrySof Natural IQ (SN60WF) IOL

Device

AcrySof Natural IQ (SN60WF) intraocular lens implanted in the capsular bag during cataract surgery. The IOL is intended for the lifetime of the patient.

Primary outcomes

  1. Total ocular high-order aberrations

    Time frame: Month 1 postoperative

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

A Comparative Pilot Study Of High-Order Aberrations With Aspheric Intraocular Lens (IOL) Models SN60WF And ZCB00

Important dates

Study start
2010
Primary completion
2011
First posted
Apr 16, 2010
Registry last updated
Nov 29, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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