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

Primary Purpose

Cataracts

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acrysof IQ (SN60WF) IOL
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataracts focused on measuring intraocular lens, cataracts, total residual spherical aberration, high order aberrations

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Contact Alcon Call Center for Trial Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Acrysof IQ (SN60WF) IOL

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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.
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.
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.
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.
Quality of Vision Questionnaire
As completed by the participant.

Full Information

First Posted
August 26, 2010
Last Updated
November 27, 2012
Sponsor
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT01190631
Brief Title
An Assessment of Residual Spherical Aberration, Postoperative Total High Order Aberrations, and Functional Vision Correlation Following Intraocular Lens (IOL) Implantation
Official Title
An Assessment of Residual Spherical Aberration, Postoperative Total High Order Aberrations, and Functional Vision Correlation After SN60WF IOL Implantation
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataracts
Keywords
intraocular lens, cataracts, total residual spherical aberration, high order aberrations

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare Provider
Allocation
Non-Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acrysof IQ (SN60WF) IOL
Arm Type
Experimental
Arm Description
AcrySof IQ SN60WF intraocular lens (IOL) implanted in one eye only during cataract surgery.
Intervention Type
Device
Intervention Name(s)
Acrysof IQ (SN60WF) IOL
Other Intervention Name(s)
Acrysof® IQ Model SN60WF
Intervention Description
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.
Primary Outcome Measure Information:
Title
Contrast Sensitivity
Description
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.
Time Frame
Day 90 postoperative
Secondary Outcome Measure Information:
Title
Total Higher Order Aberrations
Description
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).
Time Frame
Day 90 postoperative
Title
Corneal Spherical Aberration
Description
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.
Time Frame
Day 90 postoperative
Title
Uncorrected Visual Acuity (UCVA)
Description
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.
Time Frame
Day 90 postoperative
Title
Best Corrected Visual Acuity (BCVA)
Description
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.
Time Frame
Day 90 postoperative
Title
Low Contrast (10%) Visual Acuity
Description
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.
Time Frame
Day 90 postoperative
Title
Quality of Vision Questionnaire
Description
As completed by the participant.
Time Frame
Day 90 postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Contact Alcon Call Center for Trial Locations
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76134
Country
United States

12. IPD Sharing Statement

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

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