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Optimizing the Assessment of Refractive Outcomes After Cataract Surgery

Primary Purpose

Cataract

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Manifest refraction
ACRYSOF® IQ Monofocal IOL Model SN60WF
Topcon® KR-1W Wave-Front Analyzer
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cataract focused on measuring Intraocular Lens (IOL)

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Able to understand and sign an Ethics Committee/Institutional Review Board approved Informed Consent;
  • Willing and able to attend all scheduled study visits as required per protocol;
  • Diagnosed with cataract in one or both eyes;
  • Planned cataract removal by phacoemulsification with implantation of a monofocal IOL; laser refractive procedures for incisions (primary and sideport), capsulorhexis and lens fragmentation are allowed;
  • Preoperative keratometric astigmatism ≤ 1.0 diopter (D);
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Women of childbearing potential, pregnant, or breast-feeding;
  • History of ocular pathology, ocular inflammation, or ocular conditions, as specified in the protocol;
  • Previous intraocular or corneal surgery;
  • Use of systemic medications that, in the opinion of the Investigator, may confound the outcome or increase the risk of complications to the subject;
  • Any medical condition that, in the opinion of the Investigator, may confound the results of this study, prohibit the completion of the study assessments, or increase the risk for the subject;
  • Other protocol-defined exclusion criteria may apply.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Manifest refraction

    Arm Description

    Manifest refraction performed by autorefraction (automated) and manual procedures (standard). Subject implanted with ACRYSOF® IQ Monofocal IOL Model SN60WF. Autorefraction performed by Topcon® KR-1W Wave-Front Analyzer.

    Outcomes

    Primary Outcome Measures

    IOL A-constant at 3 Months at Each Site
    The A-constant, is a type of IOL constant, that accounts for clinical variables that may affect the refractive outcome (e.g. patient factors, biometry method). It relates the power of the IOL to axial length and corneal measurements. It is specific to the design of the IOL, style, and placement within the eye. The optimization of the A-constant is fundamental to achieving the targeted refractive outcomes, offset any observed error and for ensuring high patient satisfaction following cataract surgery. Since errors/noise from refraction plays a significant role in A-constant optimization, it is important to determine if an automated method has any advantages over conventional manifest refraction. A-constants based on autorefraction and manifest refraction for the study eye are compared for each subject. The mean difference between the two methods cannot be greater than 0.15 D at each of the three study centers for the methods to be considered equivalent.

    Secondary Outcome Measures

    Full Information

    First Posted
    July 14, 2016
    Last Updated
    December 19, 2018
    Sponsor
    Alcon Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02842151
    Brief Title
    Optimizing the Assessment of Refractive Outcomes After Cataract Surgery
    Official Title
    Optimizing the Assessment of Refractive Outcomes After Cataract Surgery and Implantation of a Monofocal IOL
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    September 21, 2016 (Actual)
    Primary Completion Date
    November 16, 2017 (Actual)
    Study Completion Date
    November 16, 2017 (Actual)

    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 is to evaluate current available assessments (automated vs. manual) with which manifest refraction data and biometric variables are obtained to understand if data from an automated refractor can be utilized to optimize the A-constant as well as manual subjective refraction (ie, to a clinically insignificant difference). The A-constant is the calculated number that helps the surgeon determine which IOL should be implanted in the eye during cataract surgery.
    Detailed Description
    Subjects will be implanted with ACRYSOF® IQ Monofocal IOL Model SN60WF. Standard clinical practice will be followed for pre-operative testing, IOL power estimation and IOL implantation. Only one eye will be enrolled in the study per surgeon determination. The eye will undergo both an automated and manual manifest refraction assessment at 3 months postoperative.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cataract
    Keywords
    Intraocular Lens (IOL)

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    Outcomes Assessor
    Allocation
    N/A
    Enrollment
    162 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Manifest refraction
    Arm Type
    Other
    Arm Description
    Manifest refraction performed by autorefraction (automated) and manual procedures (standard). Subject implanted with ACRYSOF® IQ Monofocal IOL Model SN60WF. Autorefraction performed by Topcon® KR-1W Wave-Front Analyzer.
    Intervention Type
    Procedure
    Intervention Name(s)
    Manifest refraction
    Intervention Description
    Manifest refraction performed by autorefraction (automated) and manual procedures (standard)
    Intervention Type
    Device
    Intervention Name(s)
    ACRYSOF® IQ Monofocal IOL Model SN60WF
    Intervention Description
    Monofocal IOL implanted for long-term use over the lifetime of the cataract patient
    Intervention Type
    Device
    Intervention Name(s)
    Topcon® KR-1W Wave-Front Analyzer
    Intervention Description
    Wavefront and topography system used to obtain autorefraction data
    Primary Outcome Measure Information:
    Title
    IOL A-constant at 3 Months at Each Site
    Description
    The A-constant, is a type of IOL constant, that accounts for clinical variables that may affect the refractive outcome (e.g. patient factors, biometry method). It relates the power of the IOL to axial length and corneal measurements. It is specific to the design of the IOL, style, and placement within the eye. The optimization of the A-constant is fundamental to achieving the targeted refractive outcomes, offset any observed error and for ensuring high patient satisfaction following cataract surgery. Since errors/noise from refraction plays a significant role in A-constant optimization, it is important to determine if an automated method has any advantages over conventional manifest refraction. A-constants based on autorefraction and manifest refraction for the study eye are compared for each subject. The mean difference between the two methods cannot be greater than 0.15 D at each of the three study centers for the methods to be considered equivalent.
    Time Frame
    Month 3 (Day 80-100) Post Study Eye Implantation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    22 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Able to understand and sign an Ethics Committee/Institutional Review Board approved Informed Consent; Willing and able to attend all scheduled study visits as required per protocol; Diagnosed with cataract in one or both eyes; Planned cataract removal by phacoemulsification with implantation of a monofocal IOL; laser refractive procedures for incisions (primary and sideport), capsulorhexis and lens fragmentation are allowed; Preoperative keratometric astigmatism ≤ 1.0 diopter (D); Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Women of childbearing potential, pregnant, or breast-feeding; History of ocular pathology, ocular inflammation, or ocular conditions, as specified in the protocol; Previous intraocular or corneal surgery; Use of systemic medications that, in the opinion of the Investigator, may confound the outcome or increase the risk of complications to the subject; Any medical condition that, in the opinion of the Investigator, may confound the results of this study, prohibit the completion of the study assessments, or increase the risk for the subject; Other protocol-defined exclusion criteria may apply.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Alcon, A Novartis Division
    Organizational Affiliation
    Alcon, A Novartis Division
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Optimizing the Assessment of Refractive Outcomes After Cataract Surgery

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