search
Back to results

Clinical Investigation of Visual Function After Bilateral Implantation of Two Presbyopia-Correcting Trifocal Intraocular Lenses (IOL)

Primary Purpose

Cataracts

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL
AT LISA® tri IOL
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataracts

Eligibility Criteria

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

Inclusion Criteria:

  • Diagnosis of bilateral cataracts with planned clear cornea cataract removal;
  • Able to comprehend and willing to sign informed consent and complete all required postoperative follow-up procedures;
  • Calculated lens power between 13.0 and 30.0 Diopters (D);
  • Preoperative Best-corrected distance visual acuity (BCDVA) worse than 0.20 logMAR (ie, 0.22 logMAR or worse) in at least one eye;
  • Potential postoperative BCDVA of 0.20 logMAR or better in both eyes. Note: Subjects with any pathology that could reduce visual potential should not be enrolled in this trial;
  • Preoperative regular corneal astigmatism of < 1.00 D, in both eyes;
  • Clear intraocular media other than cataract in both eyes;
  • Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

  • Reasonably expected to require an ocular surgical treatment at any time during the study (other than YAG capsulotomy);
  • Previous refractive surgery or planned refractive surgery procedures throughout the entire duration of participation in the clinical study (including, but not limited to LASIK, astigmatic keratotomy and limbal relaxing incisions);
  • Clinically significant corneal abnormalities including corneal dystrophy, inflammation or edema;
  • Amblyopia;
  • Previous corneal transplant;
  • Any recurrent severe anterior or posterior segment inflammation of any etiology, and/or history of any disease producing an intraocular inflammatory reaction;
  • Rubella, congenital, traumatic, or complicated cataracts;
  • Glaucoma (uncontrolled or controlled with medication);
  • Degenerative eye disorders;
  • History of or current retinal conditions or predisposition to retinal conditions, previous history of, or a predisposition to, retinal detachment or presence of diabetic retinopathy;
  • Optic nerve atrophy;
  • Expected to require retinal laser treatment;
  • Color vision deficiencies;
  • Pregnant or lactating (current or planned during the course of the study);
  • Other protocol-specified exclusion criteria may apply.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    TFNT00

    839MP

    Arm Description

    AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL, bilateral implantation

    AT LISA® tri IOL, bilateral implantation

    Outcomes

    Primary Outcome Measures

    Least Squares Mean Binocular Uncorrected Intermediate Visual Acuity (UCIVA) (60cm) at Day 120-180
    VA was tested binocularly (both eyes together) with no refractive correction in place using an early treatment diabetic retinopathy study (ETDRS) chart set at 60 cm. VA was measured in "logarithm of the minimum angle of resolution" (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity.

    Secondary Outcome Measures

    Least Squares Mean Binocular UCIVA (60cm) at Day 120-180
    VA was tested binocularly with no refractive correction in place using an ETDRS chart set at 60 cm. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity.
    Least Squares Mean Binocular Uncorrected Distance VA (4m) at Day 120-180
    VA was tested binocularly with no refractive correction in place using an ETDRS chart set at 4 meters. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity.
    Least Squares Mean Binocular Uncorrected Near VA (40cm) at Day 120-180
    VA was tested binocularly with no refractive correction in place using an ETDRS chart set at 40 cm. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity.
    Mean Photopic Binocular Defocus Curve at Day 120-180
    A defocus curve is created by multiple measurements of one's visual acuity (VA) at different spherical powers. VA was measured in logMAR. A lower logMAR value indicates better visual acuity. No statistical test was performed.
    Mean Photopic Without Glare Binocular Distance Contrast Sensitivity at Day 120-180
    Contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly in lighted conditions with distance manifest correction in place and uncorrected, with no glare source illumination. Contrast sensitivity was assessed at spatial frequencies of 3, 6, 12, and 18 cycles per degree (CPD) and reported in log units. A higher numeric value represents better contrast sensitivity. No statistical test was performed.
    Mean Photopic With Glare Binocular Distance Contrast Sensitivity at Day 120-180
    Contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly in lighted conditions with distance manifest correction in place and uncorrected, with glare source illumination. Contrast sensitivity was assessed at spatial frequencies of 3, 6, 12, and 18 CPDs and reported in log units. A higher numeric value represents better contrast sensitivity. No statistical test was performed.
    Mean Mesopic Without Glare Binocular Distance Contrast Sensitivity at Day 120-180
    Contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly in dim to dark conditions with distance manifest correction in place and uncorrected, with no glare source illumination. Contrast sensitivity was assessed at spatial frequencies of 1.5, 3, 6, and 12 CPDs and reported in log units. A higher numeric value represents better contrast sensitivity. No statistical test was performed.
    Mean Mesopic With Glare Binocular Distance Contrast Sensitivity at Day 120-180
    Contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly with distance manifest correction in place and uncorrected, with glare source illumination. Contrast sensitivity was assessed at spatial frequencies of 1.5, 3, 6, and 12 CPDs and reported in log units. A higher numeric value represents better contrast sensitivity. No statistical test was performed.
    Subject Satisfaction Recorded at Day 120-180
    At the Month 6 Visit, subjects responded to the question: "Given your current postoperative vision, if you had to do it all over would you have the same lens implanted again?". Responses were reported as a percentage of subjects. No statistical test was performed.

    Full Information

    First Posted
    February 22, 2016
    Last Updated
    September 25, 2019
    Sponsor
    Alcon Research
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02691741
    Brief Title
    Clinical Investigation of Visual Function After Bilateral Implantation of Two Presbyopia-Correcting Trifocal Intraocular Lenses (IOL)
    Official Title
    Clinical Investigation of Visual Function After Bilateral Implantation of Two Presbyopia-Correcting Trifocal IOLs
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    April 29, 2016 (Actual)
    Primary Completion Date
    July 17, 2017 (Actual)
    Study Completion Date
    July 17, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Alcon Research

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to clinically evaluate the visual performance of two commercially available presbyopia-correcting Trifocal IOLs.
    Detailed Description
    Subjects will attend a total of 9 visits (6 postoperative) over a 7 month period.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    215 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    TFNT00
    Arm Type
    Experimental
    Arm Description
    AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL, bilateral implantation
    Arm Title
    839MP
    Arm Type
    Active Comparator
    Arm Description
    AT LISA® tri IOL, bilateral implantation
    Intervention Type
    Device
    Intervention Name(s)
    AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL
    Other Intervention Name(s)
    Model TFNT00
    Intervention Description
    Trifocal IOL(near, intermediate, distance) implanted for long-term use over the lifetime of the cataract patient
    Intervention Type
    Device
    Intervention Name(s)
    AT LISA® tri IOL
    Other Intervention Name(s)
    Model 839MP
    Intervention Description
    Trifocal IOL(near, intermediate, distance) implanted for long-term use over the lifetime of the cataract patient
    Primary Outcome Measure Information:
    Title
    Least Squares Mean Binocular Uncorrected Intermediate Visual Acuity (UCIVA) (60cm) at Day 120-180
    Description
    VA was tested binocularly (both eyes together) with no refractive correction in place using an early treatment diabetic retinopathy study (ETDRS) chart set at 60 cm. VA was measured in "logarithm of the minimum angle of resolution" (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity.
    Time Frame
    Day 120-180 from second eye implantation
    Secondary Outcome Measure Information:
    Title
    Least Squares Mean Binocular UCIVA (60cm) at Day 120-180
    Description
    VA was tested binocularly with no refractive correction in place using an ETDRS chart set at 60 cm. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity.
    Time Frame
    Day 120-180 from second eye implantation
    Title
    Least Squares Mean Binocular Uncorrected Distance VA (4m) at Day 120-180
    Description
    VA was tested binocularly with no refractive correction in place using an ETDRS chart set at 4 meters. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity.
    Time Frame
    Day 120-180 from second eye implantation
    Title
    Least Squares Mean Binocular Uncorrected Near VA (40cm) at Day 120-180
    Description
    VA was tested binocularly with no refractive correction in place using an ETDRS chart set at 40 cm. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity.
    Time Frame
    Day 120-180 from second eye implantation
    Title
    Mean Photopic Binocular Defocus Curve at Day 120-180
    Description
    A defocus curve is created by multiple measurements of one's visual acuity (VA) at different spherical powers. VA was measured in logMAR. A lower logMAR value indicates better visual acuity. No statistical test was performed.
    Time Frame
    Day 120-180 from second eye implantation
    Title
    Mean Photopic Without Glare Binocular Distance Contrast Sensitivity at Day 120-180
    Description
    Contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly in lighted conditions with distance manifest correction in place and uncorrected, with no glare source illumination. Contrast sensitivity was assessed at spatial frequencies of 3, 6, 12, and 18 cycles per degree (CPD) and reported in log units. A higher numeric value represents better contrast sensitivity. No statistical test was performed.
    Time Frame
    Day 120-180 from second eye implantation
    Title
    Mean Photopic With Glare Binocular Distance Contrast Sensitivity at Day 120-180
    Description
    Contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly in lighted conditions with distance manifest correction in place and uncorrected, with glare source illumination. Contrast sensitivity was assessed at spatial frequencies of 3, 6, 12, and 18 CPDs and reported in log units. A higher numeric value represents better contrast sensitivity. No statistical test was performed.
    Time Frame
    Day 120-180 from second eye implantation
    Title
    Mean Mesopic Without Glare Binocular Distance Contrast Sensitivity at Day 120-180
    Description
    Contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly in dim to dark conditions with distance manifest correction in place and uncorrected, with no glare source illumination. Contrast sensitivity was assessed at spatial frequencies of 1.5, 3, 6, and 12 CPDs and reported in log units. A higher numeric value represents better contrast sensitivity. No statistical test was performed.
    Time Frame
    Day 120-180 from second eye implantation
    Title
    Mean Mesopic With Glare Binocular Distance Contrast Sensitivity at Day 120-180
    Description
    Contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly with distance manifest correction in place and uncorrected, with glare source illumination. Contrast sensitivity was assessed at spatial frequencies of 1.5, 3, 6, and 12 CPDs and reported in log units. A higher numeric value represents better contrast sensitivity. No statistical test was performed.
    Time Frame
    Day 120-180 from second eye implantation
    Title
    Subject Satisfaction Recorded at Day 120-180
    Description
    At the Month 6 Visit, subjects responded to the question: "Given your current postoperative vision, if you had to do it all over would you have the same lens implanted again?". Responses were reported as a percentage of subjects. No statistical test was performed.
    Time Frame
    Day 120-180 from second eye implantation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    22 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosis of bilateral cataracts with planned clear cornea cataract removal; Able to comprehend and willing to sign informed consent and complete all required postoperative follow-up procedures; Calculated lens power between 13.0 and 30.0 Diopters (D); Preoperative Best-corrected distance visual acuity (BCDVA) worse than 0.20 logMAR (ie, 0.22 logMAR or worse) in at least one eye; Potential postoperative BCDVA of 0.20 logMAR or better in both eyes. Note: Subjects with any pathology that could reduce visual potential should not be enrolled in this trial; Preoperative regular corneal astigmatism of < 1.00 D, in both eyes; Clear intraocular media other than cataract in both eyes; Other protocol-specified inclusion criteria may apply. Exclusion Criteria: Reasonably expected to require an ocular surgical treatment at any time during the study (other than YAG capsulotomy); Previous refractive surgery or planned refractive surgery procedures throughout the entire duration of participation in the clinical study (including, but not limited to LASIK, astigmatic keratotomy and limbal relaxing incisions); Clinically significant corneal abnormalities including corneal dystrophy, inflammation or edema; Amblyopia; Previous corneal transplant; Any recurrent severe anterior or posterior segment inflammation of any etiology, and/or history of any disease producing an intraocular inflammatory reaction; Rubella, congenital, traumatic, or complicated cataracts; Glaucoma (uncontrolled or controlled with medication); Degenerative eye disorders; History of or current retinal conditions or predisposition to retinal conditions, previous history of, or a predisposition to, retinal detachment or presence of diabetic retinopathy; Optic nerve atrophy; Expected to require retinal laser treatment; Color vision deficiencies; Pregnant or lactating (current or planned during the course of the study); Other protocol-specified exclusion criteria may apply.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sr. Clinical Manager, GCRA
    Organizational Affiliation
    Alcon, a Novartis Company
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Clinical Investigation of Visual Function After Bilateral Implantation of Two Presbyopia-Correcting Trifocal Intraocular Lenses (IOL)

    We'll reach out to this number within 24 hrs