Clinical Evaluation of the One-Piece Tecnis Multifocal Intraocular Lens (IOL)

Sponsor
Abbott Medical Optics (Industry)
Overall Status
Completed
CT.gov ID
NCT01210807
Collaborator
(none)
70
4
2
21
17.5
0.8

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate near vision of the One-Piece Tecnis Multifocal lens (ZMB00) vs. the One-piece Tecnis monofocal lens (ZCB00)and additionally evaluate general postoperative outcomes of the One-Piece Tecnis Multifocal lens.

Condition or Disease Intervention/Treatment Phase
  • Device: One-Piece Tecnis Multifocal IOL
  • Device: One-Piece Tecnis monofocal IOL, Model ZCB00
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
70 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Clinical Evaluation of the One-Piece Tecnis Multifocal IOL, Model ZMB00
Study Start Date :
Nov 1, 2009
Actual Primary Completion Date :
Aug 1, 2011
Actual Study Completion Date :
Aug 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: Multifocal Intraocular Lens

ZMB00 multifocal intraocular lens

Device: One-Piece Tecnis Multifocal IOL
One-piece Tecnis Multifocal IOL, Model ZMB00, implanted lens.
Other Names:
  • Model ZMB00
  • Active Comparator: Monofocal Intraocular Lens

    ZCB00 monofocal intraocular lens

    Device: One-Piece Tecnis monofocal IOL, Model ZCB00
    Control lens: One-Piece Tecnis monofocal IOL, Model, ZCB00, implanted lens.
    Other Names:
  • ZCB00
  • Outcome Measures

    Primary Outcome Measures

    1. Mean LogMAR Binocular Photopic Distance Corrected Near Visual Acuity at 33 cm [4-6 Months]

      Snellen equivalent for the mean logMAR binocular photopic distance corrected near visual acuity at 33 cm is 20/24 for the Multifocal Group. Snellen equivalent for the mean logMAR binocular photopic distance corrected near visual acuity at 33 cm is 20/81 for the Monofocal Group.

    Secondary Outcome Measures

    1. Number of Subjects With 20/40 or Better Best Corrected Binocular Distance Visual Acuity [4-6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • bilateral cataracts and otherwise healthy eyes

    • visual potential of Decimal 0.8 in each eye

    Exclusion Criteria:
    • any medications affecting vision

    • any chronic disease/illness that would affect risk to subject or outcomes of the study

    • any ocular pathology/abnormalities that may affect visual outcomes or confound study results

    • desire for monovision

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Augenarzte Gemeinschaftspraxis Ahaus Ahaus Germany 48683
    2 University Eye Clinic Heidelberg Germany 69120
    3 Klinikum Ernst von Bergmann gGmbH Potsdam Germany 14467
    4 University Eye Clinic Tubingen Germany 72076

    Sponsors and Collaborators

    • Abbott Medical Optics

    Investigators

    • Principal Investigator: Peter Szurman, PD Dr. med.,

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Abbott Medical Optics
    ClinicalTrials.gov Identifier:
    NCT01210807
    Other Study ID Numbers:
    • DIOL-105-TMF1
    First Posted:
    Sep 29, 2010
    Last Update Posted:
    Nov 1, 2015
    Last Verified:
    Oct 1, 2015
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title ZMB00 Multifocal Intraocular Lens ZCB00 Monofocal Intraocular Lens
    Arm/Group Description Subjects bilaterally implanted with the Model ZMB00 Multifocal Intraocular Lens Subjects bilaterally implanted with the Model ZCB00 Monofocal Intraocular Lens
    Period Title: Overall Study
    STARTED 36 34
    COMPLETED 33 31
    NOT COMPLETED 3 3

    Baseline Characteristics

    Arm/Group Title ZMB00 Multifocal Intraocular Lens ZCB00 Monofocal Intraocular Lens Total
    Arm/Group Description Subjects bilaterally implanted with the Model ZMB00 Multifocal Intraocular Lens Subjects bilaterally implanted with the Model ZCB00 Monofocal Intraocular Lens Total of all reporting groups
    Overall Participants 34 33 67
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    63.1
    (11.4)
    68.3
    (11.3)
    65.9
    (11.6)
    Sex: Female, Male (Count of Participants)
    Female
    23
    67.6%
    17
    51.5%
    40
    59.7%
    Male
    11
    32.4%
    16
    48.5%
    27
    40.3%

    Outcome Measures

    1. Secondary Outcome
    Title Number of Subjects With 20/40 or Better Best Corrected Binocular Distance Visual Acuity
    Description
    Time Frame 4-6 months

    Outcome Measure Data

    Analysis Population Description
    Within the 4-6 month time frame, one assessment was performed per participant. Though 70 subjects started the study (36 ZMB00; 34 ZCB00), best corrected binocular diatance visual acuity data were available for only 32 ZMB00 and 31 ZCB00 subjects at the the 4-6 month visit.
    Arm/Group Title ZMB00 Multifocal Intraocular Lens ZCB00 Monofocal Intraocular Lens
    Arm/Group Description Subjects bilaterally implanted with the Model ZMB00 Multifocal Intraocular Lens Subjects bilaterally implanted with the Model ZCB00 Monofocal Intraocular Lens
    Measure Participants 32 31
    Number [participants]
    32
    94.1%
    31
    93.9%
    2. Primary Outcome
    Title Mean LogMAR Binocular Photopic Distance Corrected Near Visual Acuity at 33 cm
    Description Snellen equivalent for the mean logMAR binocular photopic distance corrected near visual acuity at 33 cm is 20/24 for the Multifocal Group. Snellen equivalent for the mean logMAR binocular photopic distance corrected near visual acuity at 33 cm is 20/81 for the Monofocal Group.
    Time Frame 4-6 Months

    Outcome Measure Data

    Analysis Population Description
    Within the 4-6 month time frame, one assessment was performed per participant. Though 70 subjects started the study (36 ZMB00; 34 ZCB00), data for logMAR binocular photopic distance corrected near visual acuity at 33 were available for only 33 ZMB00 and 31 ZCB00 subjects at the the 4-6 month visit.
    Arm/Group Title ZMB00 Multifocal Intraocular Lens ZCB00 Monofocal Intraocular Lens
    Arm/Group Description Subjects bilaterally implanted with the Model ZMB00 Multifocal Intraocular Lens Subjects bilaterally implanted with the Model ZCB00 Monofocal Intraocular Lens
    Measure Participants 33 31
    Mean (Standard Deviation) [logMAR visual acuity]
    0.07
    (0.12)
    0.61
    (0.15)

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title ZMB00 Multifocal Intraocular Lens ZCB00 Monofocal Intraocular Lens
    Arm/Group Description Subjects bilaterally implanted with the Model ZMB00 Multifocal Intraocular Lens Subjects bilaterally implanted with the Model ZCB00 Monofocal Intraocular Lens
    All Cause Mortality
    ZMB00 Multifocal Intraocular Lens ZCB00 Monofocal Intraocular Lens
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    ZMB00 Multifocal Intraocular Lens ZCB00 Monofocal Intraocular Lens
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/36 (0%) 0/34 (0%)
    Other (Not Including Serious) Adverse Events
    ZMB00 Multifocal Intraocular Lens ZCB00 Monofocal Intraocular Lens
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 3/36 (8.3%) 4/34 (11.8%)
    Eye disorders
    Macular edema 1/36 (2.8%) 1 1/34 (2.9%) 1
    Vitreous detachment 1/36 (2.8%) 1 0/34 (0%) 0
    IOL replacement secondary to broken haptic during surgery 0/36 (0%) 0 1/34 (2.9%) 1
    Wound leakage 0/36 (0%) 0 1/34 (2.9%) 1
    Injury, poisoning and procedural complications
    Head injury secondary to car accident 1/36 (2.8%) 1 0/34 (0%) 0
    Head and shoulder injury secondary to wheelchair malfunction 0/36 (0%) 0 1/34 (2.9%) 1

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

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

    Results Point of Contact

    Name/Title PD Dr. med. Peter Szurman
    Organization University Eye Clinic, Tubingen, Germany
    Phone 49-7071-29-84915
    Email peter.szurman@med.uni-tuebingen.de
    Responsible Party:
    Abbott Medical Optics
    ClinicalTrials.gov Identifier:
    NCT01210807
    Other Study ID Numbers:
    • DIOL-105-TMF1
    First Posted:
    Sep 29, 2010
    Last Update Posted:
    Nov 1, 2015
    Last Verified:
    Oct 1, 2015