Depth of Focus Comparison Between Acrysof IQ and Acrysof Natural IOLs

NCT00886249 | Withdrawn

• 1 other identifier: HR#29924
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate and compare the depth of focus and visual outcomes after implantation of the Acrysof IQ SN60WF aspheric intraocular lens (IOL) and the Acrysof Natural SN60AT spherical IOL.

Conditions

Cataract; Vision

Keywords

Vision; Eye; Cataract

Outcome Measures

Primary Outcomes (1)

• The purpose of this study is to evaluate and compare depth of focus and visual outcomes in eyes receiving the aspheric Acrysof IQ and those receiving the spherical Acrysof Natural IOL after routine cataract extraction.

  six months

Interventions

Acrysof IQ DEVICE

Intraocular lens

Also known as: Acrysof IQ SN60WF aspheric intraocular lens

Acrysof Natural IOL DEVICE

Intraocular Lens

Also known as: Acrysof Natural SN60AT spherical IOL

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

A total of 50 patients of both sexes and any race undergoing routine bilateral phacoemulsification and intraocular lens implantation will be included.

You may qualify if:

• Subject must have an age-related cataract in both eyes;
• Subject must be 40 years of age or older;
• Subject must desire cataract extraction;
• Expected maximum of 2 weeks and minimum of 1 week interval between the first and second eye surgeries; AND
• Subject must be willing and able to comply with scheduled visits and other study procedures.

You may not qualify if:

• Preoperative ocular pathology: amblyopia, shallow anterior chamber, aniridia, history of iritis, iris neovascularization or iris atrophy, uveitis, medically uncontrolled glaucoma or advanced glaucomatous damage, rubella cataract, diabetic retinopathy, macular edema, retinal detachment, microphtalmus or macrophtalmus, optic nerve atrophy, macular degeneration (with anticipated best postoperative visual acuity less than 20/30), etc.;
• Keratometric astigmatism exceeding 1.5 diopters;
• Uncontrolled diabetes;
• Use of any systemic or topical drug known to interfere with visual performance;
• Contact lens use during the active treatment portion of the trial;
• Any concurrent infectious/non infectious conjunctivitis, keratitis or uveitis;
• Pregnant or nursing mothers and females of childbearing potential not practicing a reliable and medically acceptable method of birth control;
• Any clinically significant, serious or severe medical or psychiatric condition that may increase the risk associated with study participation or study device implantation or may interfere with the interpretation of study results;
• Participation in (or current participation) any investigational drug or device trial within the previous 30 days prior to the start date of this trial.
• Prior history of eye surgery;
• Other ocular surgery at the time of the cataract extraction (except limbal relaxing incisions, LRI); OR
• History of trauma.
• The study lens should not be implanted and the patient should be excluded from the study if any of the following complications are encountered during surgery:
• Significant anterior chamber bleeding;
• Detached Descemet's membrane;

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina, Storm Eye Institute

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Helga P Sandoval, MD

  Associate Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 21, 2009
• First Posted: April 22, 2009
• Study Start: March 1, 2009
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: June 7, 2018

Record last verified: 2009-10

Locations

US (1)