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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01190631
First received: August 26, 2010
Last updated: November 27, 2012
Last verified: November 2012
  Purpose

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).


Condition Intervention
Cataracts
Device: Acrysof IQ (SN60WF) IOL

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: An Assessment of Residual Spherical Aberration, Postoperative Total High Order Aberrations, and Functional Vision Correlation After SN60WF IOL Implantation

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Contrast Sensitivity [ Time Frame: Day 90 postoperative ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Total Higher Order Aberrations [ Time Frame: Day 90 postoperative ] [ Designated as safety issue: No ]
    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).

  • Corneal Spherical Aberration [ Time Frame: Day 90 postoperative ] [ Designated as safety issue: No ]
    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.

  • Uncorrected Visual Acuity (UCVA) [ Time Frame: Day 90 postoperative ] [ Designated as safety issue: No ]
    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.

  • Best Corrected Visual Acuity (BCVA) [ Time Frame: Day 90 postoperative ] [ Designated as safety issue: No ]
    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.

  • Low Contrast (10%) Visual Acuity [ Time Frame: Day 90 postoperative ] [ Designated as safety issue: No ]
    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.

  • Quality of Vision Questionnaire [ Time Frame: Day 90 postoperative ] [ Designated as safety issue: No ]
    As completed by the participant.


Enrollment: 100
Study Start Date: July 2010
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Acrysof® IQ Model SN60WF

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01190631

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

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01190631     History of Changes
Other Study ID Numbers: M-10-008
Study First Received: August 26, 2010
Last Updated: November 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Alcon Research:
intraocular lens
cataracts
total residual spherical aberration
high order aberrations

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on August 28, 2014