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Visual Performance of Four Types of Multifocal Intraocular Lenses (presbyopia)

Primary Purpose

Cataract

Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
multifocal intraocular lens IOLs
Sponsored by
Shahid Beheshti University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Preoperative BCVA (distance) more impacted than 20/40
  • Glare VA test comes about worse than 20/40, or practically impairing dissensions about their vision.
  • By reviewing and judging the researchers, individuals also had a potential need for visual acuity of 20/30 or better after surgery.
  • Express a want for multifocal vision, and be ready and ready to conform to the investigation necessities

Exclusion Criteria:

  • Excluded from entry were subjects with regular astigmatism greater than 1.5 D or irregular astigmatism.
  • Large pupil
  • Corneal transplant surgery or previous glaucoma-filtering,
  • A history of retinal detachments.
  • Also excluded were patients with other clinically non-cataract ocular abnormality (e.g. chronic drug-induced miosis,
  • Endothelial disease
  • Iris neovascularization, and amblyopia)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    AMO Tecnis Symfony

    AcrySof ReSTOR (Alcon Laboratories)

    AT Lisa tri (CarlZeiss Meditec AG)

    PanOptix(Alcon Laboratories)

    Arm Description

    Multifocal with extended range of vision, Diffractive, No Preloaded, Aspheric, +3.25 D near add and +2.17 D intermediate 6.0mm Hydrophilic -0.20 Has nine diffractive steps, The proprietary achromatic technology corrects chromatic aberration. This creates improved contrast sensitivity.

    Multifocal ,Diffractive, +3.00D and for Near, Aspheric, Has 9 steps (rings), Light: 41% for far; 41% for near: 18% reflected (lost). 6.0mm Silicone -0.10 Bifocal ,One piece,Blue filter ,Central diffractive region of 3.6_mm for near and distance vision ,Apodised ,peripheral refractive region is dedicated to distance vision

    Trifocal, diffractive, +3.33 D near add and +1.66 D intermediate add at the IOL plane, aspheric (aberration correcting) Optic Diameter 6.0 mm Total Diameter 11.0 mm Haptic Angulation 0° Lens Design Single-piece, MICS Incision Size 1.8 mm Company Labeled A-Constant1 118.6 Diopter Range 0.0 to +32.0 D, 0.5 D increments ACD 5.32

    Trifocal,Difractive,+3.25D Near,+2.17 D intermediate 6.0mm hydrophobic -0.27 One piece ,aspheric , Focal 4.5 mm (15 diffractive zones)

    Outcomes

    Primary Outcome Measures

    Contrast sensitivity
    mean postoperative contrast sensitivity in logarithmic scale under binocular mesopic and photopic conditions. There was no significant difference in the values obtained between at lisa tri and PanOptix at spatial frequencies of 1 cpd and 3, 6, 12, 18 cpd. Eyes with the PanOptix and at lisa tri IOL showed better contrast sensitivity than ReSTOR and Symfony at spatial frequencies of 1, 3, 6 cpd (P<0.001) in photopic and mesopic conditions. The curves achieved with monocular vision were equivalent with binocular vision that was achieved.

    Secondary Outcome Measures

    Full Information

    First Posted
    January 25, 2018
    Last Updated
    April 10, 2022
    Sponsor
    Shahid Beheshti University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03454334
    Brief Title
    Visual Performance of Four Types of Multifocal Intraocular Lenses
    Acronym
    presbyopia
    Official Title
    To Compare the Clinical Results of Different Multifocal Intraocular Lenses (IOLs) in Patients With Presbyopia or Cataracts
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2020
    Overall Recruitment Status
    Terminated
    Study Start Date
    August 11, 2013 (Actual)
    Primary Completion Date
    November 18, 2019 (Actual)
    Study Completion Date
    January 14, 2020 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Shahid Beheshti University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Device Product Not Approved or Cleared by U.S. FDA
    Yes
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This investigation assessed the visual performance of presbyopia and cataract patients after bilateral implantation of 4 distinct sorts of multifocal IOLs: At lisa tri, PanOptix, ReSTOR, and Symfony. The clinical results demonstrated here were excellent for four groups, however, there were also differences in group ReSTOR, UCVA and BCVA for the intermediate and near of the other groups showed less vision also symphony group for far distance demonstrated less vision than other groups, which may be related to their design.Multifocal IOLs demonstrated very good technology and unquestionably have a place in refractive surgery, whether for clear lens extraction or cataracts.Patients can expect excellent outcomes and surgeons can expect patients to be very satisfied with surgical outcomes. Four groups multifocal lenses provided excellent distance, intermediate and near vision, but several measures indicated that the PanOptix and at lisa tri lens provided better vision in all distances. Spectacle independence was significantly higher with four groups. Multifocal IOL design might play a role in the postsurgical outcome, because better results were obtained with diffractive lenses. Although there were differences in the results of these four lenses in the study, all of the results were acceptable.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cataract

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Non-Randomized
    Enrollment
    141 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    AMO Tecnis Symfony
    Arm Type
    Active Comparator
    Arm Description
    Multifocal with extended range of vision, Diffractive, No Preloaded, Aspheric, +3.25 D near add and +2.17 D intermediate 6.0mm Hydrophilic -0.20 Has nine diffractive steps, The proprietary achromatic technology corrects chromatic aberration. This creates improved contrast sensitivity.
    Arm Title
    AcrySof ReSTOR (Alcon Laboratories)
    Arm Type
    Active Comparator
    Arm Description
    Multifocal ,Diffractive, +3.00D and for Near, Aspheric, Has 9 steps (rings), Light: 41% for far; 41% for near: 18% reflected (lost). 6.0mm Silicone -0.10 Bifocal ,One piece,Blue filter ,Central diffractive region of 3.6_mm for near and distance vision ,Apodised ,peripheral refractive region is dedicated to distance vision
    Arm Title
    AT Lisa tri (CarlZeiss Meditec AG)
    Arm Type
    Active Comparator
    Arm Description
    Trifocal, diffractive, +3.33 D near add and +1.66 D intermediate add at the IOL plane, aspheric (aberration correcting) Optic Diameter 6.0 mm Total Diameter 11.0 mm Haptic Angulation 0° Lens Design Single-piece, MICS Incision Size 1.8 mm Company Labeled A-Constant1 118.6 Diopter Range 0.0 to +32.0 D, 0.5 D increments ACD 5.32
    Arm Title
    PanOptix(Alcon Laboratories)
    Arm Type
    Active Comparator
    Arm Description
    Trifocal,Difractive,+3.25D Near,+2.17 D intermediate 6.0mm hydrophobic -0.27 One piece ,aspheric , Focal 4.5 mm (15 diffractive zones)
    Intervention Type
    Device
    Intervention Name(s)
    multifocal intraocular lens IOLs
    Intervention Description
    clinical outcome of different multifocal intraocular lenses (IOLs) in patients with presbyopia or cataracts
    Primary Outcome Measure Information:
    Title
    Contrast sensitivity
    Description
    mean postoperative contrast sensitivity in logarithmic scale under binocular mesopic and photopic conditions. There was no significant difference in the values obtained between at lisa tri and PanOptix at spatial frequencies of 1 cpd and 3, 6, 12, 18 cpd. Eyes with the PanOptix and at lisa tri IOL showed better contrast sensitivity than ReSTOR and Symfony at spatial frequencies of 1, 3, 6 cpd (P<0.001) in photopic and mesopic conditions. The curves achieved with monocular vision were equivalent with binocular vision that was achieved.
    Time Frame
    4 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Preoperative BCVA (distance) more impacted than 20/40 Glare VA test comes about worse than 20/40, or practically impairing dissensions about their vision. By reviewing and judging the researchers, individuals also had a potential need for visual acuity of 20/30 or better after surgery. Express a want for multifocal vision, and be ready and ready to conform to the investigation necessities Exclusion Criteria: Excluded from entry were subjects with regular astigmatism greater than 1.5 D or irregular astigmatism. Large pupil Corneal transplant surgery or previous glaucoma-filtering, A history of retinal detachments. Also excluded were patients with other clinically non-cataract ocular abnormality (e.g. chronic drug-induced miosis, Endothelial disease Iris neovascularization, and amblyopia)

    12. IPD Sharing Statement

    Learn more about this trial

    Visual Performance of Four Types of Multifocal Intraocular Lenses

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