An Assessment of Residual Spherical Aberration, Postoperative Total High Order Aberrations, and Functional Vision Correlation Following Intraocular Lens (IOL) Implantation

An Assessment of Residual Spherical Aberration, Postoperative Total High Order Aberrations, and Functional Vision Correlation After SN60WF IOL Implantation

The purpose of this study was to evaluate total residual spherical aberration (TSA) post-IOL implantation, and to determine if an association exists between TSA, postoperative high order aberrations (HOA), and functional vision following IOL implantation in patients grouped by pre-operative corneal spherical aberration (CSA).

Study Overview

• Status: Completed
• Conditions: Cataracts
• Intervention / Treatment: Device: Acrysof IQ (SN60WF) IOL

Detailed Description

Patients will be grouped by pre-operative corneal spherical aberration (CSA) measures, i.e., ≤0.230 micron and ≥0.270 micron.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Fort Worth, Texas, United States, 76134
      • Contact Alcon Call Center for Trial Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age-related cataract grade 3 or lower in at least one eye;
• Planned cataract removal via phacoemulsification with an implantation of an aspheric IOL;
• Able to have an operation within 30 days of preoperative evaluation;
• Good ocular health, with the exception of cataracts;
• ≤ 1.50 diopter (D) of preoperative astigmatism by keratometry;
• Willing and able to understand and sign an informed consent;
• Willing and able to attend postoperative examinations per protocol schedule;
• Able to achieve 6.5mm dilated pupil;
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Preoperative ocular pathology as specified in protocol;
• Preoperative corneal pathology as specified in protocol;
• Keratometric astigmatism exceeding 1.50 diopter;
• Planned postoperative refraction for mono-vision;
• 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;
• 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;
• Intraocular conventional surgery within the past three months or intraocular laser surgery within one month in the operated eye;
• Pregnant or nursing mothers and females of childbearing potential not practicing a reliable and medically acceptable method of birth control;
• Other protocol-defined exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acrysof IQ (SN60WF) IOL; AcrySof IQ SN60WF intraocular lens (IOL) implanted in one eye only during cataract surgery.	Device: Acrysof IQ (SN60WF) IOL; Acrysof IQ (SN60WF) intraocular lens implanted in the capsular bag of the eye during cataract surgery. The IOL is intended for the lifetime of the patient. Unilateral (one eye only) implantation is planned.; Other Names: Acrysof® IQ Model SN60WF

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Contrast Sensitivity	Contrast sensitivity is the measurement of one's ability to detect slight changes in luminance before it becomes indistinguishable. It is measured in logarithmic units by means of an illuminated box, the CSV 1000 by Vector Vision. A higher value for the logarithmic units translates to better contrast sensitivity.	Day 90 postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Higher Order Aberrations	A higher order aberration is a distortion acquired by a wavefront light when it passes through an eye with irregularities of its refractive components (tear film, cornea, aqueous humor, crystalline lens and vitreous humor). It is measured via wavefront measurements according to manufacturer's instructions with a LADARWave (Alcon Laboratories, Inc., Ft. Worth TX).	Day 90 postoperative
Corneal Spherical Aberration	Corneal spherical aberration is the blurring of an image that occurs when light from the margin of a lens or mirror with a spherical surface comes to a shorter focus than light from the central portion. The changing focal length is caused by deviations in the lens or mirror surface from a true sphere and is measured by corneal topography with a commercially available topographer in accordance with manufacturer's guidelines.	Day 90 postoperative
Uncorrected Visual Acuity (UCVA)	Uncorrected visual acuity, i.e., visual acuity without any type of corrective lenses, is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution," and a lower logMAR value indicates better visual acuity.	Day 90 postoperative
Best Corrected Visual Acuity (BCVA)	Best corrected visual acuity, i.e., visual correction utilizing a phoropter or trial frames, is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution," and a lower logMAR value indicates better visual acuity.	Day 90 postoperative
Low Contrast (10%) Visual Acuity	Visual acuity is tested using 10% contrast ETDRS (Early Treatment Diabetic Retinopathy Study) charts under photopic conditions. Testing is performed using the correction from the manifest refraction at a distance calibrated for the chart. Visual acuity (VA) is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution," and a lower logMAR value indicates better visual acuity.	Day 90 postoperative
Quality of Vision Questionnaire	As completed by the participant.	Day 90 postoperative

Collaborators and Investigators

• Sponsor: Alcon Research

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): November 1, 2011
• Study Completion: December 7, 2022

Study Registration Dates

• First Submitted: August 26, 2010
• First Submitted That Met QC Criteria: August 26, 2010
• First Posted (Estimate): August 27, 2010

Study Record Updates

• Last Update Posted (Estimate): November 29, 2012
• Last Update Submitted That Met QC Criteria: November 27, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: intraocular lens; cataracts; total residual spherical aberration; high order aberrations
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: M-10-008

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No