Corrected VA With Long-Term Follow-Up After AcrySof® Intraocular Lens (IOL) Implantation

Sponsor
Alcon, a Novartis Company (Industry)
Overall Status
Completed
CT.gov ID
NCT02450799
Collaborator
(none)
104
Enrollment
3
Arms
11
Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the long-term visual acuity (VA) with an acrylic IOL to a silicone or polymethylmethacrylate (PMMA) IOL in cataract patients. This study will take place in Japan.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: Acrylic IOL
  • Device: Silicone IOL
  • Device: PMMA IOL
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
104 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Official Title:
Corrected VA With Long-Term Follow-Up After AcrySof® IOL Implantation
Study Start Date :
Jun 1, 2015
Actual Primary Completion Date :
May 1, 2016
Actual Study Completion Date :
May 1, 2016

Arms and Interventions

ArmIntervention/Treatment
Experimental: AcrySof IOL

Acrylic IOL, prior implantation (1994-2000) in one or both eyes

Device: Acrylic IOL
Acrylic IOL for long-term implantation in the cataract patient
Other Names:
  • AcrySof® Model MA30BA
  • AcrySof® Model MA60BM
  • Active Comparator: Silicone IOL

    Silicone IOL, prior implantation (1994-2000) in one or both eyes

    Device: Silicone IOL
    Silicone IOL for long-term implantation in the cataract patient

    Active Comparator: PMMA IOL

    PMMA IOL, prior implantation (1994-2000) in one or both eyes

    Device: PMMA IOL
    Polymethylmethacrylate IOL for long-term implantation in the cataract patient

    Outcome Measures

    Primary Outcome Measures

    1. Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at the Long-Term, Post-Implantation Visit [Baseline (up to and including 3 months after implantation), long-term post-implantation visit (14-20 years after implantation)]

      Measurement of best corrected (with spectacles or other visual corrective devices) visual acuity (at both near and distance). Visual Acuity (VA) is measured in logMAR (logarithm of the minimum angle of resolution). A lower logMAR value indicates better visual acuity. One eye (study eye) contributed to the analysis.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Willing to provide voluntary consent and able to comprehend and sign the informed consent form;

    • Pseudophakic patients implanted with an Acrylic (AcrySof®), PMMA or silicone IOL from 1994 to 2000;

    • Clear intraocular media in study eye;

    • Best-corrected visual acuity (decimal) within 3 months post-implantation of 0.8 (decimal VA chart) or more in study eye;

    • No ocular or systemic condition which may affect visual acuity in study eye;

    • Other protocol-specified inclusion criteria may apply.

    Exclusion Criteria:
    • Complications that may impact visual acuity in study eye at the time of the prospective visit, such as glaucoma, diabetic retinitis, ocular inflammatory disease, retinal detachment, and others as specified in the protocol;

    • Previous refractive surgery in study eye;

    • Previous IOL exchange in study eye;

    • Other protocol-specified exclusion criteria may apply.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Alcon, a Novartis Company

    Investigators

    • Study Director: Group Manager, Clinical Dev., Alcon Japan, Ltd.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alcon, a Novartis Company
    ClinicalTrials.gov Identifier:
    NCT02450799
    Other Study ID Numbers:
    • ILQ245-P001
    • UMIN000017727
    First Posted:
    May 21, 2015
    Last Update Posted:
    Dec 9, 2016
    Last Verified:
    Oct 1, 2016
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment DetailsSubjects were recruited from 11 study centers located in Japan.
    Pre-assignment DetailOf the 104 enrolled, 6 subjects were exited as screen failures and deemed ineligible for participation. This reporting group includes all eligible subjects (98).
    Arm/Group TitleAcrySofSiliconePMMA
    Arm/Group DescriptionAcrylic IOL, prior implantation (1994-2000) in one or both eyesSilicone IOL, prior implantation (1994-2000) in one or both eyesPolymethylmethacrylate (PMMA) IOL, prior implantation (1994-2000) in one or both eyes
    Period Title: Overall Study
    STARTED313730
    COMPLETED313730
    NOT COMPLETED000

    Baseline Characteristics

    Arm/Group TitleAcrySofSiliconePMMATotal
    Arm/Group DescriptionAcrylic IOL, prior implantation (1994-2000) in one or both eyesSilicone IOL, prior implantation (1994-2000) in one or both eyesPolymethylmethacrylate IOL, prior implantation (1994-2000) in one or both eyesTotal of all reporting groups
    Overall Participants31373098
    Age, Customized (subjects) [Number]
    <70 years
    2
    4
    6
    12
    ≥70 and ≤79 years
    13
    21
    11
    45
    ≥80 and ≤89 years
    12
    12
    9
    33
    >90 years
    4
    0
    4
    8
    Sex: Female, Male (Count of Participants)
    Female
    23
    74.2%
    24
    64.9%
    19
    63.3%
    66
    67.3%
    Male
    8
    25.8%
    13
    35.1%
    11
    36.7%
    32
    32.7%

    Outcome Measures

    1. Primary Outcome
    TitleMean Change From Baseline in Best Corrected Visual Acuity (BCVA) at the Long-Term, Post-Implantation Visit
    DescriptionMeasurement of best corrected (with spectacles or other visual corrective devices) visual acuity (at both near and distance). Visual Acuity (VA) is measured in logMAR (logarithm of the minimum angle of resolution). A lower logMAR value indicates better visual acuity. One eye (study eye) contributed to the analysis.
    Time FrameBaseline (up to and including 3 months after implantation), long-term post-implantation visit (14-20 years after implantation)

    Outcome Measure Data

    Analysis Population Description
    This analysis population includes all subjects who used the study devices and have data after implantation of study devices (Full Analysis Set).
    Arm/Group TitleAcrySofSiliconePMMA
    Arm/Group DescriptionAcrylic IOL, prior implantation (1994-2000) in one or both eyesSilicone IOL, prior implantation (1994-2000) in one or both eyesPolymethylmethacrylate IOL, prior implantation (1994-2000) in one or both eyes
    Measure Participants313730
    Baseline
    -0.06
    (0.07)
    -0.09
    (0.07)
    -0.07
    (0.08)
    Change from baseline
    0.01
    (0.08)
    0.04
    (0.06)
    -0.01
    (0.05)

    Adverse Events

    Time FrameAdverse events (AEs) were collected for the duration of a subject's participation in the study; retrospectively 14 to 20 years and prospectively for a single visit. This analysis group includes all subjects who used the study devices and underwent the long-term post-implantation visit examination. Ocular adverse events are presented for both study eye and non-study eye combined.
    Adverse Event Reporting Description An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, whether or not related to the investigational medical device (test/control article or procedure). AEs are reported retrospectively (onset between Baseline (defined as the period within 3 months after surgery) and Informed Consent acquisition) and prospectively (onset after Informed Consent acquisition).
    Arm/Group TitleAcrySof (Retrospective)Silicone (Retrospective)PMMA (Retrospective)AcrySof (Prospective)Silicone (Prospective)PMMA (Prospective)
    Arm/Group DescriptionSubjects with prior implantation of acrylic IOL who experienced an AE related to decrease of BCVA in the study eyeSubjects with prior implantation of Silicone IOL who experienced an AE related to decrease of BCVA in the study eyeSubjects with prior implantation of PMMA IOL who experienced an AE related to decrease of BCVA in the study eyeSubjects with prior implantation of acrylic IOL who experienced an AE with onset after the Informed Consent acquisitionSubjects with prior implantation of Silicone IOL who experienced an AE with onset after the Informed Consent acquisitionSubjects with prior implantation of PMMA IOL who experienced an AE with onset after the Informed Consent acquisition
    All Cause Mortality
    AcrySof (Retrospective)Silicone (Retrospective)PMMA (Retrospective)AcrySof (Prospective)Silicone (Prospective)PMMA (Prospective)
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total/ (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    AcrySof (Retrospective)Silicone (Retrospective)PMMA (Retrospective)AcrySof (Prospective)Silicone (Prospective)PMMA (Prospective)
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/31 (0%) 0/37 (0%) 0/30 (0%) 0/31 (0%) 0/37 (0%) 0/30 (0%)
    Other (Not Including Serious) Adverse Events
    AcrySof (Retrospective)Silicone (Retrospective)PMMA (Retrospective)AcrySof (Prospective)Silicone (Prospective)PMMA (Prospective)
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/31 (0%) 3/37 (8.1%) 4/30 (13.3%) 0/31 (0%) 0/37 (0%) 0/30 (0%)
    Eye disorders
    posterior capsule opacification0/31 (0%) 3/37 (8.1%) 4/30 (13.3%) 0/31 (0%) 0/37 (0%) 0/30 (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/TitlePhase IV, Clinical and Regulatory Affairs, Alcon Japan
    OrganizationAlcon, A Novartis Division
    Phone1-888-451-3937
    Emailalcon.medinfo@alcon.com
    Responsible Party:
    Alcon, a Novartis Company
    ClinicalTrials.gov Identifier:
    NCT02450799
    Other Study ID Numbers:
    • ILQ245-P001
    • UMIN000017727
    First Posted:
    May 21, 2015
    Last Update Posted:
    Dec 9, 2016
    Last Verified:
    Oct 1, 2016