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

NCT01190631 | Completed

• 1 other identifier: M-10-008
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Cataracts

Keywords

intraocular lens; cataracts; total residual spherical aberration; high order aberrations

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Total Higher Order Aberrations

  Day 90 postoperative

• Corneal Spherical Aberration

  Day 90 postoperative

• Uncorrected Visual Acuity (UCVA)

  Day 90 postoperative

• Best Corrected Visual Acuity (BCVA)

  Day 90 postoperative

• Low Contrast (10%) Visual Acuity

  Day 90 postoperative

Study Arms (1)

Acrysof IQ (SN60WF) IOL

EXPERIMENTAL

AcrySof IQ SN60WF intraocular lens (IOL) implanted in one eye only during cataract surgery.

Device: Acrysof IQ (SN60WF) IOL

Interventions

Acrysof IQ (SN60WF) IOL DEVICE

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.

Also known as: Acrysof® IQ Model SN60WF

Acrysof IQ (SN60WF) IOL

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (1)

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, 76134, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2010
• First Posted: August 27, 2010
• Study Start: July 1, 2010
• Primary Completion: November 1, 2011
• Last Updated: November 29, 2012

Record last verified: 2012-11

Locations

US (1)