A Clinical Study of the ACRYSOF® IQ Extended Depth of Focus Intraocular Lens (IOL)

Sponsor
Alcon Research (Industry)
Overall Status
Completed
CT.gov ID
NCT03274986
Collaborator
(none)
242
Enrollment
11
Locations
2
Arms
12.2
Actual Duration (Months)
22
Patients Per Site
1.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study is to demonstrate the safety and performance of ACRYSOF IQ extended depth of focus (EDF) intraocular lens (IOL) at Month 6. Depth of focus (DOF) is the amount of focal plane displacement behind a lens that does not degrade the image quality of a distant object. A larger DOF allows sharp images of closer objects and may provide improved vision at intermediate and near distances.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: ACRYSOF® IQ Extended Depth of Focus IOL
  • Device: ACRYSOF® IQ Monofocal IOL
  • Procedure: Cataract surgery
N/A

Detailed Description

Both eyes of a subject must require cataract surgery to qualify for enrollment into this study. Subjects participating in the trial will attend a total of 9 scheduled study visits over a 7-8 month period. Of the 9 visits, 1 is preoperative, 2 are operative, and the remaining 6 are postoperative visits. Primary endpoint data will be collected at the Month 6 (Day 120-180) post second eye implantation visit.

Study Design

Study Type:
Interventional
Actual Enrollment :
242 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Prospective, Randomized, Controlled, Multi-Center Clinical Study of the ACRYSOF® IQ Extended Depth of Focus IOL
Actual Study Start Date :
Oct 11, 2017
Actual Primary Completion Date :
Oct 16, 2018
Actual Study Completion Date :
Oct 16, 2018

Arms and Interventions

ArmIntervention/Treatment
Experimental: DFT015

ACRYSOF® IQ Extended Depth of Focus Intraocular lens (IOL), bilateral implantation

Device: ACRYSOF® IQ Extended Depth of Focus IOL
Implantable IOL intending to extend the depth of focus and provide continuous functional vision from distance to near while maintaining distance vision and a visual disturbance profile comparable to a monofocal IOL.
Other Names:
  • Model DFT015
  • Procedure: Cataract surgery
    IOL bilateral implantation

    Active Comparator: SN60WF

    ACRYSOF® IQ Monofocal IOL, bilateral implantation

    Device: ACRYSOF® IQ Monofocal IOL
    Monofocal IOL implanted for long-term use over the lifetime of the pseudophakic subject
    Other Names:
  • Model SN60WF
  • Procedure: Cataract surgery
    IOL bilateral implantation

    Outcome Measures

    Primary Outcome Measures

    1. Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) [(Logarithm of the Minimum Angle of Resolution (logMAR)] 66 Centimeters (cm) From Spectacle Plane [Month 6 (120-180 days post second eye implantation)]

      Visual acuity (VA) was tested monocularly (each eye separately) under photopic (well-lit) conditions using best distance correction adjusted for optical infinity, electronic Early Treatment Diabetic Retinopathy Study (ETDRS) charts at a distance of 66 cm from the spectacle plane. DCIVA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. This analysis was prespecified for the first operative eye.

    2. Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA) logMAR [(4 Meters (m)] From Spectacle Plane [Month 6 (120-180 days post second eye implantation)]

      VA was tested monocularly under photopic conditions using the correction obtained from the best correction and no optical infinity adjustment, electronic ETDRS charts at a distance of 4 m from the spectacle plane. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. This analysis was prespecified for the first operative eye.

    3. Monocular Depth of Focus (Measured in the Negative Direction From 0) at 0.20 logMAR From the Mean Defocus Curve [Month 6 (120-180 days post second eye implantation)]

      Depth of focus was assessed at 4 meters under photopic (well-lit) conditions using best corrected distance refraction and added defocus. The depth of focus was estimated as the dioptric range between zero defocus and the first point on the negative lens induced mean defocus curve that crosses the 0.2 logMAR using a linear interpolation. A lower numeric value represents better VA. This analysis was pre-specified for the first operative eye. No formal statistical hypothesis testing was planned.

    4. Percentage of Eyes Achieving Monocular Photopic DCIVA 0.20 logMAR or Better [Month 6 (120-180 days post second eye implantation)]

      VA was tested monocularly under photopic conditions using best distance correction adjusted for optical infinity, electronic ETDRS charts at a distance of 66 cm from the eye. DCIVA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. This analysis was prespecified for the first operative eye. No formal statistical hypothesis testing was planned.

    5. Percentage of Subjects With Ocular Adverse Events [Day 0 (first operative eye visit), up to Month 6 (120-180 days post second eye implantation)]

      An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device (test article). Ocular AEs are events localized to the eye. Cumulative and persistent serious adverse events as defined in ISO 11979-7:2014 were collected. This outcome measure was prespecified for the Model DFT015 first and second eyes. No formal statistical hypothesis testing was planned.

    6. Mesopic Contrast Sensitivity [Month 6 (120-180 days post second eye implantation)]

      Contrast sensitivity (i.e., the ability to detect objects by distinguishing them from their background) was assessed monocularly with the subject's best spectacle correction under mesopic (low, but not quite dark) conditions at a distance of 8 (2.45 m) feet from the eye at a spatial frequency of 1.5, 3, 6, and 12 cycles per degree (cpd) using the Vector Vision CSV 1000-HGT with and without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. A higher numeric value represented better contrast sensitivity. This analysis was prespecified for the first operative eye. No formal statistical hypothesis testing was planned.

    Secondary Outcome Measures

    1. Monocular Photopic Distance Corrected Near Visual Acuity (DCNVA) (logMAR) 40 cm From Spectacle Plane [Month 6 (120-180 days post second eye implantation)]

      VA was tested monocularly under photopic conditions using best distance correction adjusted for optical infinity, electronic ETDRS chart set at 40 cm from the spectacle plane. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. This analysis was prespecified for the first operative eye.

    2. Percentage of Subjects Who Respond "Never" to Question 1 of the Intraocular Lens Satisfaction (IOLSAT) Questionnaire: "Overall, in the Past 7 Days, How Often Did You Need to Wear Eyeglasses to See?" [Month 6 (120-180 days post second eye implantation)]

      The IOLSAT questionnaire assessed the subjective quality of vision with respect to need for spectacles, as well as the subject's expectation and satisfaction with their quality of vision at 6 months. Results are reported consistent with multiple testing strategy.

    3. Monocular Photopic Uncorrected Intermediate Visual Acuity (UCIVA) (logMAR) 66 cm From Spectacle Plane [Month 6 (120-180 days post second eye implantation)]

      VA was tested monocularly under photopic conditions with no refractive correction or adjustment for optical infinity, using electronic ETDRS charts at a distance of 66 cm from the spectacle plane. UCIVA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. This analysis was prespecified for the first operative eye. No formal statistical hypothesis testing was planned.

    4. Monocular Photopic Uncorrected Distance Visual Acuity (UCDVA) (logMAR) [Month 6 (120-180 days post second eye implantation)]

      VA was tested monocularly under photopic conditions without refractive correction but with adjustment for optical infinity, electronic ETDRS charts at a distance of 4 m from the eye. +0.25 D spherical power was applied to correct for optical infinity. UCDVA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA.This analysis was prespecified for the first operative eye. No formal statistical hypothesis testing was planned.

    5. Percentage of Subjects With Visual Disturbances as Reported by the Subjects Using the Questionnaire for Visual Disturbances (QUVID) [Month 6 (120-180 days post second eye implantation)]

      Rates of severe and most bothersome visual disturbances as reported by the subjects on the QUVID questionnaire, a Patient Reported Outcome (PRO) questionnaire. No formal statistical hypothesis testing was planned.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    22 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Best Corrected Distance Visual Acuity (BCDVA) of 0.3 logarithm of the minimum angle of resolution (logMAR) (20/40 Snellen) or worse either with or without a glare source present (e.g., Brightness Acuity Tester)

    • Preoperative regular astigmatism of < 1.0 D in both eyes

    • Clear intraocular media other than cataract

    • Diagnosed with cataract in both eyes

    • Planned cataract removal by routine small incision surgery

    • Calculated lens power between 18.0 and 25.0 diopter (D) [when targeted for emmetropia (0.0 D)]

    • Willing and able to complete all required postoperative visits

    • Able to comprehend and sign an ethics committee-approved statement of informed consent

    • Potential postoperative BCDVA of 0.2 logMAR (20/32 Snellen) or better in each eye based on Investigator's medical opinion.

    Exclusion Criteria:
    • History of eye pathology and/or inflammation, as specified in the protocol

    • Clinically significant/severe ocular surface disease that would affect study measurements based on Investigator expert medical opinion

    • History of previous intraocular or corneal surgery

    • Pregnant/lactating or has another condition with associated fluctuation of hormones that could lead to refractive changes

    • Taking systemic medications that in the Investigator's best medical judgment may confound the outcome or increase the risk to the subject.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Alcon Investigative SiteBirminghamAlabamaUnited States35213
    2Alcon Investigative SiteFort CollinsColoradoUnited States80528
    3Alcon Investigative SiteBradentonFloridaUnited States34209
    4Alcon Investigative SiteSebringFloridaUnited States33870
    5Alcon Investigative SiteGainesvilleGeorgiaUnited States30501
    6Alcon Investigative SiteRock IslandIllinoisUnited States61201
    7Alcon Investigative SiteCincinnatiOhioUnited States45242
    8Alcon Investigative SiteAllenwoodPennsylvaniaUnited States17810
    9Alcon Investigative SiteKingstonPennsylvaniaUnited States18704
    10Alcon Investigative SiteWest MifflinPennsylvaniaUnited States15122
    11Alcon Investigative SiteSioux FallsSouth DakotaUnited States57108

    Sponsors and Collaborators

    • Alcon Research

    Investigators

    • Study Director: Alcon Research, Alcon Research

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Alcon Research
    ClinicalTrials.gov Identifier:
    NCT03274986
    Other Study ID Numbers:
    • ILI875-C002
    First Posted:
    Sep 7, 2017
    Last Update Posted:
    Apr 7, 2020
    Last Verified:
    Mar 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment DetailsSubjects were recruited from 11 investigative sites located in the United States.
    Pre-assignment Detail21 subjects discontinued prior to randomization, and 1 subject discontinued after randomization but prior to attempted implantation. This reporting group includes all subjects with attempted implantation, as treated. Note: 1 subject randomized to DFT015 was implanted with SN60WF. Subject withdrew at the 1 month visit.
    Arm/Group TitleDFT015SN60WF
    Arm/Group DescriptionACRYSOF® IQ Extended Depth of Focus IOL, bilateral implantationACRYSOF® IQ Monofocal IOL, bilateral implantation
    Period Title: Overall Study
    STARTED107113
    Successful Implantation, as Treated107113
    COMPLETED107111
    NOT COMPLETED02

    Baseline Characteristics

    Arm/Group TitleDFT015SN60WFTotal
    Arm/Group DescriptionACRYSOF® IQ Extended Depth of Focus IOL, bilateral implantationACRYSOF® IQ Monofocal IOL, bilateral implantationTotal of all reporting groups
    Overall Participants107113220
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    68.8
    (7.82)
    68.8
    (6.63)
    68.8
    (7.22)
    Sex: Female, Male (Count of Participants)
    Female
    59
    55.1%
    64
    56.6%
    123
    55.9%
    Male
    48
    44.9%
    49
    43.4%
    97
    44.1%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    2
    1.9%
    2
    1.8%
    4
    1.8%
    Not Hispanic or Latino
    104
    97.2%
    111
    98.2%
    215
    97.7%
    Unknown or Not Reported
    1
    0.9%
    0
    0%
    1
    0.5%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    1
    0.9%
    1
    0.5%
    Asian
    0
    0%
    0
    0%
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    1
    0.9%
    1
    0.9%
    2
    0.9%
    White
    105
    98.1%
    110
    97.3%
    215
    97.7%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    1
    0.9%
    1
    0.9%
    2
    0.9%

    Outcome Measures

    1. Primary Outcome
    TitleMonocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) [(Logarithm of the Minimum Angle of Resolution (logMAR)] 66 Centimeters (cm) From Spectacle Plane
    DescriptionVisual acuity (VA) was tested monocularly (each eye separately) under photopic (well-lit) conditions using best distance correction adjusted for optical infinity, electronic Early Treatment Diabetic Retinopathy Study (ETDRS) charts at a distance of 66 cm from the spectacle plane. DCIVA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. This analysis was prespecified for the first operative eye.
    Time FrameMonth 6 (120-180 days post second eye implantation)

    Outcome Measure Data

    Analysis Population Description
    All-Implanted Analysis Set, as treated
    Arm/Group TitleDFT015SN60WF
    Arm/Group DescriptionACRYSOF® IQ Extended Depth of Focus IOL, bilateral implantationACRYSOF® IQ Monofocal IOL, bilateral implantation
    Measure Participants107111
    Measure Eyes107111
    Least Squares Mean (Standard Error) [logMAR]
    0.148
    (0.0120)
    0.312
    (0.0118)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection DFT015, SN60WF
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesisp-Value<0.001
    Comments2-sided p-value reported. A hypothesis test was based on a two sample t-test, with a type I error rate of 0.025, 1-sided.
    Methodt-test, 2 sided
    Comments
    Method of EstimationEstimation ParameterLeast Squares Mean Difference
    Estimated Value-0.164
    Confidence Interval (2-Sided) 95%
    -0.197 to -0.131
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.0168
    Estimation CommentsLeast squares mean difference (DFT015 - SN60WF)
    2. Primary Outcome
    TitleMonocular Photopic Best Corrected Distance Visual Acuity (BCDVA) logMAR [(4 Meters (m)] From Spectacle Plane
    DescriptionVA was tested monocularly under photopic conditions using the correction obtained from the best correction and no optical infinity adjustment, electronic ETDRS charts at a distance of 4 m from the spectacle plane. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. This analysis was prespecified for the first operative eye.
    Time FrameMonth 6 (120-180 days post second eye implantation)

    Outcome Measure Data

    Analysis Population Description
    All-Implanted Analysis Set, as treated
    Arm/Group TitleDFT015SN60WF
    Arm/Group DescriptionACRYSOF® IQ Extended Depth of Focus IOL, bilateral implantationACRYSOF® IQ Monofocal IOL, bilateral implantation
    Measure Participants107111
    Measure Eyes107111
    Least Squares Mean (Standard Error) [logMAR]
    0.016
    (0.0091)
    -0.036
    (0.0089)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection DFT015, SN60WF
    Comments
    Type of Statistical Test Non-Inferiority
    Comments Non-Inferiority margin was 0.1 logMAR.
    Statistical Test of Hypothesisp-Value
    Comments
    Method
    Comments
    Method of EstimationEstimation ParameterLeast Squares Mean Difference
    Estimated Value0.052
    Confidence Interval (1-Sided) 95%
    to 0.073
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.0127
    Estimation CommentsLeast squares mean difference (DFT015 - SN60WF). The 1-sided 95% Upper Confidence Limit is presented.
    3. Primary Outcome
    TitleMonocular Depth of Focus (Measured in the Negative Direction From 0) at 0.20 logMAR From the Mean Defocus Curve
    DescriptionDepth of focus was assessed at 4 meters under photopic (well-lit) conditions using best corrected distance refraction and added defocus. The depth of focus was estimated as the dioptric range between zero defocus and the first point on the negative lens induced mean defocus curve that crosses the 0.2 logMAR using a linear interpolation. A lower numeric value represents better VA. This analysis was pre-specified for the first operative eye. No formal statistical hypothesis testing was planned.
    Time FrameMonth 6 (120-180 days post second eye implantation)

    Outcome Measure Data

    Analysis Population Description
    All-Implanted Analysis Set, as treated. Number analyzed is the number of subjects/eyes with data available for analysis at specified defocus.
    Arm/Group TitleDFT015SN60WF
    Arm/Group DescriptionACRYSOF® IQ Extended Depth of Focus IOL, bilateral implantationACRYSOF® IQ Monofocal IOL, bilateral implantation
    Measure Participants107111
    Measure Eyes107111
    Number [diopter]
    1.53
    0.99
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection DFT015, SN60WF
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesisp-Value
    Comments
    Method
    Comments
    Method of EstimationEstimation ParameterDifference in depth of focus
    Estimated Value0.54
    Confidence Interval (2-Sided) %
    to
    Parameter Dispersion Type:
    Value:
    Estimation CommentsDifference in depth of focus (DFT015 - SN60WF)
    4. Primary Outcome
    TitlePercentage of Eyes Achieving Monocular Photopic DCIVA 0.20 logMAR or Better
    DescriptionVA was tested monocularly under photopic conditions using best distance correction adjusted for optical infinity, electronic ETDRS charts at a distance of 66 cm from the eye. DCIVA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. This analysis was prespecified for the first operative eye. No formal statistical hypothesis testing was planned.
    Time FrameMonth 6 (120-180 days post second eye implantation)

    Outcome Measure Data

    Analysis Population Description
    All-Implanted Analysis Set, as treated.
    Arm/Group TitleDFT015SN60WF
    Arm/Group DescriptionACRYSOF® IQ Extended Depth of Focus IOL, bilateral implantationACRYSOF® IQ Monofocal IOL, bilateral implantation
    Measure Participants107111
    Measure Eyes107111
    Number [percentage of eyes]
    72.9
    25.2
    5. Primary Outcome
    TitlePercentage of Subjects With Ocular Adverse Events
    DescriptionAn adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device (test article). Ocular AEs are events localized to the eye. Cumulative and persistent serious adverse events as defined in ISO 11979-7:2014 were collected. This outcome measure was prespecified for the Model DFT015 first and second eyes. No formal statistical hypothesis testing was planned.
    Time FrameDay 0 (first operative eye visit), up to Month 6 (120-180 days post second eye implantation)

    Outcome Measure Data

    Analysis Population Description
    This analysis population included all eyes with attempted IOL implantation (successful or aborted after contact with the eye) (Safety Analysis Set).
    Arm/Group TitleDFT015 First EyeDFT015 Second Eye
    Arm/Group DescriptionAll eyes with attempted test article implantation (successful or aborted after contact with the eye) in the first implanted eyeAll eyes with attempted test article implantation (successful or aborted after contact with the eye) in the second implanted eye
    Measure Participants107106
    Measure Eyes107106
    Cumulative: Cystoid macular oedema
    0.9
    0.0
    Cumulative: Hypopyon
    0.0
    0.0
    Cumulative: Endophthalmitis
    0.0
    0.0
    Cumulative: Lens dislocated from posterior chamber
    0.0
    0.0
    Cumulative: Pupillary block
    0.0
    0.0
    Cumulative: Retinal detachment
    0.0
    0.0
    Cumulative: Secondary surgical intervention
    0.0
    1.9
    Cumulative: Cataract operation complication
    0.0
    1.9
    Cumulative: Hyphaema
    0.9
    0.0
    Cumulative: Transient ischaemic attack
    0.9
    0.0
    Persistent: Corneal stroma oedema
    0.0
    0.0
    Persistent: Cystoid macular oedema
    0.0
    0.0
    Persistent: Iritis
    0.0
    0.0
    Persistent: Raised IOP requiring treatment
    0.0
    0.0
    6. Primary Outcome
    TitleMesopic Contrast Sensitivity
    DescriptionContrast sensitivity (i.e., the ability to detect objects by distinguishing them from their background) was assessed monocularly with the subject's best spectacle correction under mesopic (low, but not quite dark) conditions at a distance of 8 (2.45 m) feet from the eye at a spatial frequency of 1.5, 3, 6, and 12 cycles per degree (cpd) using the Vector Vision CSV 1000-HGT with and without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. A higher numeric value represented better contrast sensitivity. This analysis was prespecified for the first operative eye. No formal statistical hypothesis testing was planned.
    Time FrameMonth 6 (120-180 days post second eye implantation)

    Outcome Measure Data

    Analysis Population Description
    Safety Analysis Set. Number analyzed is the number of subjects/eyes with data available for analysis at without glare and with glare assessments.
    Arm/Group TitleDFT015SN60WF
    Arm/Group DescriptionACRYSOF® IQ Extended Depth of Focus IOL, bilateral implantationACRYSOF® IQ Monofocal IOL, bilateral implantation
    Measure Participants107113
    Measure Eyes107113
    1.5 cpd Without Glare
    1.506
    (0.2560)
    1.498
    (0.2434)
    3 cpd Without Glare
    1.447
    (0.3381)
    1.482
    (0.2829)
    6 cpd Without Glare
    1.340
    (0.3850)
    1.548
    (0.3177)
    12 cpd Without Glare
    0.840
    (0.3681)
    1.003
    (0.3769)
    1.5 cpd With Glare
    1.504
    (0.2555)
    1.475
    (0.2569)
    3 cpd With Glare
    1.458
    (0.3304)
    1.499
    (0.2838)
    6 cpd With Glare
    1.364
    (0.3856)
    1.529
    (0.3256)
    12 cpd With Glare
    0.817
    (0.3494)
    0.999
    (0.4020)
    7. Secondary Outcome
    TitleMonocular Photopic Distance Corrected Near Visual Acuity (DCNVA) (logMAR) 40 cm From Spectacle Plane
    DescriptionVA was tested monocularly under photopic conditions using best distance correction adjusted for optical infinity, electronic ETDRS chart set at 40 cm from the spectacle plane. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. This analysis was prespecified for the first operative eye.
    Time FrameMonth 6 (120-180 days post second eye implantation)

    Outcome Measure Data

    Analysis Population Description
    All-Implanted Analysis Set, as treated.
    Arm/Group TitleDFT015SN60WF
    Arm/Group DescriptionACRYSOF® IQ Extended Depth of Focus IOL, bilateral implantationACRYSOF® IQ Monofocal IOL, bilateral implantation
    Measure Participants107111
    Measure Eyes107111
    Least Squares Mean (Standard Error) [logMAR]
    0.359
    (0.0147)
    0.515
    (0.0144)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection DFT015, SN60WF
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesisp-Value<0.001
    Comments2-sided p-value reported. A hypothesis test was based on a two sample t-test, with a type I error rate of 0.025, 1-sided.
    Methodt-test, 2 sided
    Comments
    Method of EstimationEstimation ParameterLeast Squares Mean Difference
    Estimated Value-0.156
    Confidence Interval (2-Sided) 95%
    -0.197 to -0.115
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.0206
    Estimation CommentsLeast squares mean difference (DFT015 - SN60WF)
    8. Secondary Outcome
    TitlePercentage of Subjects Who Respond "Never" to Question 1 of the Intraocular Lens Satisfaction (IOLSAT) Questionnaire: "Overall, in the Past 7 Days, How Often Did You Need to Wear Eyeglasses to See?"
    DescriptionThe IOLSAT questionnaire assessed the subjective quality of vision with respect to need for spectacles, as well as the subject's expectation and satisfaction with their quality of vision at 6 months. Results are reported consistent with multiple testing strategy.
    Time FrameMonth 6 (120-180 days post second eye implantation)

    Outcome Measure Data

    Analysis Population Description
    All-Implanted Analysis Set, as treated.
    Arm/Group TitleDFT015SN60WF
    Arm/Group DescriptionACRYSOF® IQ Extended Depth of Focus IOL, bilateral implantationACRYSOF® IQ Monofocal IOL, bilateral implantation
    Measure Participants102111
    Number [percentage of subjects]
    21.6
    3.6
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection DFT015, SN60WF
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesisp-Value
    Comments
    Method
    Comments
    Method of EstimationEstimation ParameterDifference in percentage
    Estimated Value18
    Confidence Interval (2-Sided) 95%
    9.65 to 27.37
    Parameter Dispersion Type:
    Value:
    Estimation Comments95% CI for the difference (DFT015 - SN60WF) is estimated using Miettinen-Nurminen method (1985).
    9. Secondary Outcome
    TitleMonocular Photopic Uncorrected Intermediate Visual Acuity (UCIVA) (logMAR) 66 cm From Spectacle Plane
    DescriptionVA was tested monocularly under photopic conditions with no refractive correction or adjustment for optical infinity, using electronic ETDRS charts at a distance of 66 cm from the spectacle plane. UCIVA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. This analysis was prespecified for the first operative eye. No formal statistical hypothesis testing was planned.
    Time FrameMonth 6 (120-180 days post second eye implantation)

    Outcome Measure Data

    Analysis Population Description
    All-Implanted Analysis Set, as treated.
    Arm/Group TitleDFT015SN60WF
    Arm/Group DescriptionACRYSOF® IQ Extended Depth of Focus IOL, bilateral implantationACRYSOF® IQ Monofocal IOL, bilateral implantation
    Measure Participants107111
    Measure Eyes107111
    Mean (Standard Deviation) [logMAR]
    0.136
    (0.110)
    0.261
    (0.147)
    10. Secondary Outcome
    TitleMonocular Photopic Uncorrected Distance Visual Acuity (UCDVA) (logMAR)
    DescriptionVA was tested monocularly under photopic conditions without refractive correction but with adjustment for optical infinity, electronic ETDRS charts at a distance of 4 m from the eye. +0.25 D spherical power was applied to correct for optical infinity. UCDVA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA.This analysis was prespecified for the first operative eye. No formal statistical hypothesis testing was planned.
    Time FrameMonth 6 (120-180 days post second eye implantation)

    Outcome Measure Data

    Analysis Population Description
    All-Implanted Analysis Set, as treated.
    Arm/Group TitleDFT015SN60WF
    Arm/Group DescriptionACRYSOF® IQ Extended Depth of Focus IOL, bilateral implantationACRYSOF® IQ Monofocal IOL, bilateral implantation
    Measure Participants107111
    Measure Eyes107111
    Mean (Standard Deviation) [logMAR]
    0.117
    (0.122)
    0.056
    (0.148)
    11. Secondary Outcome
    TitlePercentage of Subjects With Visual Disturbances as Reported by the Subjects Using the Questionnaire for Visual Disturbances (QUVID)
    DescriptionRates of severe and most bothersome visual disturbances as reported by the subjects on the QUVID questionnaire, a Patient Reported Outcome (PRO) questionnaire. No formal statistical hypothesis testing was planned.
    Time FrameMonth 6 (120-180 days post second eye implantation)

    Outcome Measure Data

    Analysis Population Description
    Safety Analysis Set. Number analyzed is the number of subjects/eyes with data available for analysis at specified visual disturbances.
    Arm/Group TitleDFT015SN60WF
    Arm/Group DescriptionACRYSOF® IQ Extended Depth of Focus IOL, bilateral implantationACRYSOF® IQ Monofocal IOL, bilateral implantation
    Measure Participants106113
    Severe: Starbursts
    3.8
    2.7
    Severe: Halos
    0.9
    0.9
    Severe: Glare
    0.0
    0.0
    Severe: Hazy vision
    0.0
    0.0
    Severe: Blurred vision
    0.0
    0.0
    Severe: Double vision
    0.0
    0.0
    Severe: Dark area
    0.9
    0.9
    Most Bothersome: Starbursts
    1.9
    0.9
    Most Bothersome: Halos
    0.9
    0.0
    Most Bothersome: Glare
    0.0
    0.0
    Most Bothersome: Hazy vision
    0.0
    0.0
    Most Bothersome: Blurred vision
    0.9
    1.8
    Most Bothersome: Double vision
    0.0
    0.0
    Most Bothersome: Dark area
    0.9
    0.9

    Adverse Events

    Time FramePre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
    Adverse Event Reporting Description An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
    Arm/Group TitlePreoperativeDFT015 First EyeDFT015 Second EyeDFT015 SystemicSN60WF First EyeSN60WF Second EyeSN60WF Systemic
    Arm/Group DescriptionAll subjects in the safety analysis set prior to initiation of treatmentAll eyes with attempted test article implantation (successful or aborted after contact with the eye) in the first implanted eyeAll eyes with attempted test article implantation (successful or aborted after contact with the eye) in the second implanted eyeAll subjects with attempted test article implantation (successful or aborted after contact with the eye)All eyes with attempted control article implantation (successful or aborted after contact with the eye) in the first implanted eyeAll eyes with attempted control article implantation (successful or aborted after contact with the eye) in the second implanted eyeAll subjects with attempted control article implantation (successful or aborted after contact with the eye)
    All Cause Mortality
    PreoperativeDFT015 First EyeDFT015 Second EyeDFT015 SystemicSN60WF First EyeSN60WF Second EyeSN60WF Systemic
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/220 (0%) 0/107 (0%) 0/106 (0%) 0/107 (0%) 0/113 (0%) 0/113 (0%) 0/113 (0%)
    Serious Adverse Events
    PreoperativeDFT015 First EyeDFT015 Second EyeDFT015 SystemicSN60WF First EyeSN60WF Second EyeSN60WF Systemic
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/220 (0%) 3/107 (2.8%) 2/106 (1.9%) 7/107 (6.5%) 3/113 (2.7%) 1/113 (0.9%) 4/113 (3.5%)
    Cardiac disorders
    Coronary artery disease0/220 (0%) 0/107 (0%) 0/106 (0%) 0/107 (0%) 0/113 (0%) 0/113 (0%) 1/113 (0.9%)
    Heart valve incompetence0/220 (0%) 0/107 (0%) 0/106 (0%) 0/107 (0%) 0/113 (0%) 0/113 (0%) 1/113 (0.9%)
    Eye disorders
    Cystoid macular oedema0/220 (0%) 1/107 (0.9%) 0/106 (0%) 0/107 (0%) 1/113 (0.9%) 1/113 (0.9%) 0/113 (0%)
    Photopsia0/220 (0%) 0/107 (0%) 0/106 (0%) 0/107 (0%) 1/113 (0.9%) 0/113 (0%) 0/113 (0%)
    Retinal detachment0/220 (0%) 0/107 (0%) 0/106 (0%) 0/107 (0%) 1/113 (0.9%) 0/113 (0%) 0/113 (0%)
    Hyphaema0/220 (0%) 1/107 (0.9%) 0/106 (0%) 0/107 (0%) 0/113 (0%) 0/113 (0%) 0/113 (0%)
    Gastrointestinal disorders
    Peptic ulcer0/220 (0%) 0/107 (0%) 0/106 (0%) 1/107 (0.9%) 0/113 (0%) 0/113 (0%) 0/113 (0%)
    General disorders
    Ulcer haemorrhage0/220 (0%) 0/107 (0%) 0/106 (0%) 0/107 (0%) 0/113 (0%) 0/113 (0%) 1/113 (0.9%)
    Hepatobiliary disorders
    Cholelithiasis0/220 (0%) 0/107 (0%) 0/106 (0%) 1/107 (0.9%) 0/113 (0%) 0/113 (0%) 0/113 (0%)
    Infections and infestations
    Abdominal abscess0/220 (0%) 0/107 (0%) 0/106 (0%) 1/107 (0.9%) 0/113 (0%) 0/113 (0%) 0/113 (0%)
    Pneumonia0/220 (0%) 0/107 (0%) 0/106 (0%) 2/107 (1.9%) 0/113 (0%) 0/113 (0%) 0/113 (0%)
    Injury, poisoning and procedural complications
    Bladder injury0/220 (0%) 0/107 (0%) 0/106 (0%) 1/107 (0.9%) 0/113 (0%) 0/113 (0%) 0/113 (0%)
    Cataract operation complication0/220 (0%) 0/107 (0%) 2/106 (1.9%) 0/107 (0%) 0/113 (0%) 0/113 (0%) 0/113 (0%)
    Femoral neck fracture0/220 (0%) 0/107 (0%) 0/106 (0%) 0/107 (0%) 0/113 (0%) 0/113 (0%) 1/113 (0.9%)
    Post procedural bile leak0/220 (0%) 0/107 (0%) 0/106 (0%) 1/107 (0.9%) 0/113 (0%) 0/113 (0%) 0/113 (0%)
    Spinal fracture0/220 (0%) 0/107 (0%) 0/106 (0%) 1/107 (0.9%) 0/113 (0%) 0/113 (0%) 0/113 (0%)
    Surgical procedure repeated0/220 (0%) 0/107 (0%) 2/106 (1.9%) 0/107 (0%) 0/113 (0%) 0/113 (0%) 0/113 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer0/220 (0%) 0/107 (0%) 0/106 (0%) 1/107 (0.9%) 0/113 (0%) 0/113 (0%) 0/113 (0%)
    Nervous system disorders
    Transient ischaemic attack0/220 (0%) 1/107 (0.9%) 0/106 (0%) 0/107 (0%) 0/113 (0%) 0/113 (0%) 0/113 (0%)
    Psychiatric disorders
    Panic attack0/220 (0%) 0/107 (0%) 0/106 (0%) 1/107 (0.9%) 0/113 (0%) 0/113 (0%) 0/113 (0%)
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease0/220 (0%) 0/107 (0%) 0/106 (0%) 1/107 (0.9%) 0/113 (0%) 0/113 (0%) 0/113 (0%)
    Surgical and medical procedures
    Aneurysm repair0/220 (0%) 0/107 (0%) 0/106 (0%) 0/107 (0%) 0/113 (0%) 0/113 (0%) 1/113 (0.9%)
    Lens extraction0/220 (0%) 0/107 (0%) 0/106 (0%) 0/107 (0%) 1/113 (0.9%) 0/113 (0%) 0/113 (0%)
    Vitrectomy0/220 (0%) 0/107 (0%) 0/106 (0%) 0/107 (0%) 1/113 (0.9%) 0/113 (0%) 0/113 (0%)
    Other (Not Including Serious) Adverse Events
    PreoperativeDFT015 First EyeDFT015 Second EyeDFT015 SystemicSN60WF First EyeSN60WF Second EyeSN60WF Systemic
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/220 (0%) 5/107 (4.7%) 6/106 (5.7%) 0/107 (0%) 9/113 (8%) 8/113 (7.1%) 0/113 (0%)
    Eye disorders
    Posterior capsule opacification0/220 (0%) 5/107 (4.7%) 6/106 (5.7%) 0/107 (0%) 9/113 (8%) 8/113 (7.1%) 0/113 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    Sponsor reserves the right of prior review of any publication or presentation of information related to the study.

    Results Point of Contact

    Name/TitleCDMA Project Lead
    OrganizationAlcon Research
    Phone1-888-451-3937
    Emailalcon.medinfo@alcon.com
    Responsible Party:
    Alcon Research
    ClinicalTrials.gov Identifier:
    NCT03274986
    Other Study ID Numbers:
    • ILI875-C002
    First Posted:
    Sep 7, 2017
    Last Update Posted:
    Apr 7, 2020
    Last Verified:
    Mar 1, 2020