Retrospective / Prospective Clinical Study of AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric Intraocular Lenses

Sponsor
Alcon Research (Industry)
Overall Status
Completed
CT.gov ID
NCT02176343
Collaborator
(none)
37
Enrollment
1
Arm
1.1
Actual Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study is to characterize the safety and effectiveness of the ACRYSOF IQ ReSTOR +2.5 diopter (D) Multifocal Toric Intraocular Lens (IOL) in subjects at least 3 months and no more than 14 months after IOL implantation.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL
N/A

Detailed Description

This is a retrospective and prospective clinical study comprised of a retrospective chart review for preoperative, surgical and early postoperative data, and a prospective postoperative visit conducted at least 3 months but not more than 14 months after IOL implantation.

Study Design

Study Type:
Interventional
Actual Enrollment :
37 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Retrospective / Prospective Clinical Study of AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric Intraocular Lenses
Actual Study Start Date :
Jul 21, 2014
Actual Primary Completion Date :
Aug 22, 2014
Actual Study Completion Date :
Aug 22, 2014

Arms and Interventions

ArmIntervention/Treatment
Experimental: ReSTOR Toric +2.5

AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL previously implanted during cataract surgery

Device: AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL
Multifocal IOL with extended secondary focal point and astigmatism correction implanted for long-term use over the lifetime of the cataract patient
Other Names:
  • Model SV25T2
  • Model SV25T3
  • Model SV25T4
  • Model SV25T5
  • Outcome Measures

    Primary Outcome Measures

    1. Mean Percent Reduction in Cylinder [Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)]

      Manifest refraction cylinder was measured monocularly (each eye separately) with best correction (phoropter or trial lenses) under photopic (well-lit) lighting conditions using a 100% contrast ETDRS chart at 4 meters (m) from the subject. Percent reduction in cylinder was calculated as the difference between the postoperative magnitude of manifest refractive cylinder and the preoperative magnitude of keratometric cylinder divided by the intended reduction in cylinder [defined as the difference between the intended (from toric calculator) magnitude of the postoperative manifest refractive cylinder and the preoperative keratometric cylinder], multiplied by 100%. One eye (primary eye) contributed to the analysis.

    2. Percentage of Subjects With Manifest Refraction Cylinder ≤ 0.50 D [Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)]

      Manifest refraction cylinder was measured monocularly with best correction under photopic lighting conditions using a 100% contrast ETDRS chart at 4 m from the subject. One eye (primary eye) contributed to the analysis.

    3. Percentage of Subjects (With Preoperative Astigmatism > 1.00 D) With Manifest Refraction Cylinder ≤ 1.00 D [Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)]

      Manifest refraction cylinder was measured monocularly with best correction under photopic lighting conditions using a 100% contrast ETDRS chart at 4 m from the subject. One eye (primary eye) contributed to the analysis.

    4. Mean Uncorrected Distance Visual Acuity [Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)]

      Visual Acuity (VA) was tested monocularly without visual correction under photopic (well-lit) conditions using a 100% contrast ETDRS chart positioned 4 m from the subject. A +0.25 D spherical power additional lens was used to correct for optical infinity. VA was measured in logMAR (logarithm of the minimum angle of resolution), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. One eye (primary eye) contributed to the analysis.

    5. Mean Uncorrected Near Visual Acuity [Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)]

      VA was tested monocularly without visual correction under photopic lighting conditions using a 100% contrast near ETDRS chart set at 40 cm on the nearpoint rod of the phoropter. 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. One eye (primary eye) contributed to the analysis.

    6. Mean Uncorrected Intermediate Visual Acuity [Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)]

      VA was tested monocularly without visual correction under photopic lighting conditions using a 100% contrast near ETDRS chart set at 53 cm on the nearpoint rod of the phoropter. 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. One eye (primary eye) contributed to the analysis.

    7. Mean Best Corrected Distance Visual Acuity (BCDVA) [Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)]

      VA was tested monocularly with best correction under photopic lighting conditions using a 100% contrast ETDRS chart at 4 m away from the subject. 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. One eye (primary eye) contributed to the analysis.

    8. Mean IOL Rotation [Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)]

      Lens axis orientation (position of the lens within the capsular bag) as indicated by indentations on the IOL was assessed during slit lamp examination. IOL rotation (the difference between the achieved lens axis orientation at visit and achieved axis placement at surgery) was measured in degrees. One eye (primary eye) contributed to the analysis.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Must sign an informed consent form and be willing to come in for a visit at least 3 months and not more than 14 months after IOL implantation with the AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL (Models SV25T2, SV25T3, SV25T4 and SV25T5);

    • Must be implanted with the correct lens based on preoperative corneal astigmatism as specified in the protocol;

    • Must complete a visit within 10 days after IOL implantation;

    • Successful capsular bag implantation with no surgical complications;

    • Other protocol-specified inclusion criteria may apply.

    Exclusion Criteria:
    • IOL implanted prior to the AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL;

    • Ocular or intraocular infection or inflammation at the time of the preoperative visit;

    • Any ocular surgery or intraocular laser procedure at or prior to the surgical visit;

    • Any conditions affecting the cornea (eg. corneal dystrophy, severe dry eye) at the preoperative visit;

    • Retinal conditions (e.g. degenerative retinal conditions, history of retinal detachment, diabetic retinopathy) at the preoperative visit;

    • Known history of Type 1 or 2 diabetes for more than 5 years;

    • Any ocular or systemic co-morbidity at the preoperative visit;

    • Pregnant at the preoperative visit or at the time of Postoperative Visit 2;

    • Preoperative corneal astigmatism ≤ 0.50 D;

    • Participation in another clinical study at the preoperative visit or at the time of the final study visit;

    • Other protocol-specified exclusion criteria may apply.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Alcon Research

    Investigators

    • Study Director: Clinical Manager, GCRA, Surgical, Alcon Research

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alcon Research
    ClinicalTrials.gov Identifier:
    NCT02176343
    Other Study ID Numbers:
    • C-14-005
    First Posted:
    Jun 27, 2014
    Last Update Posted:
    Jul 2, 2018
    Last Verified:
    May 1, 2017
    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
    Keywords provided by Alcon Research
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment DetailsSubjects were recruited from 4 study centers located in Australia.
    Pre-assignment DetailOf the 37 enrolled, 6 subjects were exited as screen failures and were ineligible to participate in the study. This reporting group includes all subjects who provided informed consent and were determined to be eligible based upon the inclusion and exclusion criteria (As Treated) (31).
    Arm/Group TitleReSTOR Toric +2.5
    Arm/Group DescriptionAcrySof® IQ ReSTOR® +2.5 D Multifocal Toric Intraocular Lens (IOL)
    Period Title: Overall Study
    STARTED31
    COMPLETED31
    NOT COMPLETED0

    Baseline Characteristics

    Arm/Group TitleReSTOR Toric +2.5
    Arm/Group DescriptionAcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL
    Overall Participants31
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    69.2
    (9.5)
    Sex: Female, Male (Count of Participants)
    Female
    17
    54.8%
    Male
    14
    45.2%

    Outcome Measures

    1. Primary Outcome
    TitleMean Percent Reduction in Cylinder
    DescriptionManifest refraction cylinder was measured monocularly (each eye separately) with best correction (phoropter or trial lenses) under photopic (well-lit) lighting conditions using a 100% contrast ETDRS chart at 4 meters (m) from the subject. Percent reduction in cylinder was calculated as the difference between the postoperative magnitude of manifest refractive cylinder and the preoperative magnitude of keratometric cylinder divided by the intended reduction in cylinder [defined as the difference between the intended (from toric calculator) magnitude of the postoperative manifest refractive cylinder and the preoperative keratometric cylinder], multiplied by 100%. One eye (primary eye) contributed to the analysis.
    Time FramePreoperative and Postoperative Visit (3 to 14 months after IOL implantation)

    Outcome Measure Data

    Analysis Population Description
    As Treated
    Arm/Group TitleReSTOR Toric +2.5
    Arm/Group DescriptionAcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL
    Measure Participants31
    Mean (Standard Deviation) [percent change]
    60.94
    (38.17)
    2. Primary Outcome
    TitlePercentage of Subjects With Manifest Refraction Cylinder ≤ 0.50 D
    DescriptionManifest refraction cylinder was measured monocularly with best correction under photopic lighting conditions using a 100% contrast ETDRS chart at 4 m from the subject. One eye (primary eye) contributed to the analysis.
    Time FramePreoperative and Postoperative Visit (3 to 14 months after IOL implantation)

    Outcome Measure Data

    Analysis Population Description
    As Treated
    Arm/Group TitleReSTOR Toric +2.5
    Arm/Group DescriptionAcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL
    Measure Participants31
    Number [percentage of subjects]
    67.7
    3. Primary Outcome
    TitlePercentage of Subjects (With Preoperative Astigmatism > 1.00 D) With Manifest Refraction Cylinder ≤ 1.00 D
    DescriptionManifest refraction cylinder was measured monocularly with best correction under photopic lighting conditions using a 100% contrast ETDRS chart at 4 m from the subject. One eye (primary eye) contributed to the analysis.
    Time FramePreoperative and Postoperative Visit (3 to 14 months after IOL implantation)

    Outcome Measure Data

    Analysis Population Description
    This analysis population includes all subjects who provided informed consent and were determined eligible based upon the inclusion and exclusion criteria, having preoperative astigmatism > 1.00 D.
    Arm/Group TitleReSTOR Toric +2.5
    Arm/Group DescriptionAcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL
    Measure Participants12
    Number [percentage of subjects]
    100.0
    4. Primary Outcome
    TitleMean Uncorrected Distance Visual Acuity
    DescriptionVisual Acuity (VA) was tested monocularly without visual correction under photopic (well-lit) conditions using a 100% contrast ETDRS chart positioned 4 m from the subject. A +0.25 D spherical power additional lens was used to correct for optical infinity. VA was measured in logMAR (logarithm of the minimum angle of resolution), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. One eye (primary eye) contributed to the analysis.
    Time FramePreoperative and Postoperative Visit (3 to 14 months after IOL implantation)

    Outcome Measure Data

    Analysis Population Description
    As Treated
    Arm/Group TitleReSTOR Toric +2.5
    Arm/Group DescriptionAcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL
    Measure Participants31
    Mean (Standard Deviation) [logMAR]
    0.07
    (0.12)
    5. Primary Outcome
    TitleMean Uncorrected Near Visual Acuity
    DescriptionVA was tested monocularly without visual correction under photopic lighting conditions using a 100% contrast near ETDRS chart set at 40 cm on the nearpoint rod of the phoropter. 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. One eye (primary eye) contributed to the analysis.
    Time FramePreoperative and Postoperative Visit (3 to 14 months after IOL implantation)

    Outcome Measure Data

    Analysis Population Description
    As Treated
    Arm/Group TitleReSTOR Toric +2.5
    Arm/Group DescriptionAcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL
    Measure Participants31
    Mean (Standard Deviation) [logMAR]
    0.38
    (0.16)
    6. Primary Outcome
    TitleMean Uncorrected Intermediate Visual Acuity
    DescriptionVA was tested monocularly without visual correction under photopic lighting conditions using a 100% contrast near ETDRS chart set at 53 cm on the nearpoint rod of the phoropter. 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. One eye (primary eye) contributed to the analysis.
    Time FramePreoperative and Postoperative Visit (3 to 14 months after IOL implantation)

    Outcome Measure Data

    Analysis Population Description
    As Treated
    Arm/Group TitleReSTOR Toric +2.5
    Arm/Group DescriptionAcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL
    Measure Participants31
    Mean (Standard Deviation) [logMAR]
    0.25
    (0.16)
    7. Primary Outcome
    TitleMean Best Corrected Distance Visual Acuity (BCDVA)
    DescriptionVA was tested monocularly with best correction under photopic lighting conditions using a 100% contrast ETDRS chart at 4 m away from the subject. 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. One eye (primary eye) contributed to the analysis.
    Time FramePreoperative and Postoperative Visit (3 to 14 months after IOL implantation)

    Outcome Measure Data

    Analysis Population Description
    As Treated
    Arm/Group TitleReSTOR Toric +2.5
    Arm/Group DescriptionAcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL
    Measure Participants31
    Mean (Standard Deviation) [logMAR]
    -0.03
    (0.08)
    8. Primary Outcome
    TitleMean IOL Rotation
    DescriptionLens axis orientation (position of the lens within the capsular bag) as indicated by indentations on the IOL was assessed during slit lamp examination. IOL rotation (the difference between the achieved lens axis orientation at visit and achieved axis placement at surgery) was measured in degrees. One eye (primary eye) contributed to the analysis.
    Time FramePreoperative and Postoperative Visit (3 to 14 months after IOL implantation)

    Outcome Measure Data

    Analysis Population Description
    As Treated
    Arm/Group TitleReSTOR Toric +2.5
    Arm/Group DescriptionAcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL
    Measure Participants31
    Mean (Standard Deviation) [degrees]
    3.74
    (3.86)

    Adverse Events

    Time FrameThe time period of collection of AEs was preoperative to postoperative visit 3-14 months after IOL implantation. This analysis population includes all subjects who provided informed consent and were determined eligible based upon inclusion and exclusion criteria (As Treated).
    Adverse Event Reporting Description An AE is 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 product. AEs were obtained as solicited and volunteered comments from subjects and as observations by the study Investigator as outlined in the study protocol.
    Arm/Group TitleReSTOR Toric +2.5
    Arm/Group DescriptionAll subjects implanted with AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL
    All Cause Mortality
    ReSTOR Toric +2.5
    Affected / at Risk (%)# Events
    Total0/31 (0%)
    Serious Adverse Events
    ReSTOR Toric +2.5
    Affected / at Risk (%)# Events
    Total3/31 (9.7%)
    Eye disorders
    Macular oedema1/31 (3.2%)
    Retinal vein occlusion1/31 (3.2%)
    Strabismus1/31 (3.2%)
    Infections and infestations
    Staphylococcal infection1/31 (3.2%)
    Surgical and medical procedures
    Intra-ocular injection1/31 (3.2%)
    Other (Not Including Serious) Adverse Events
    ReSTOR Toric +2.5
    Affected / at Risk (%)# Events
    Total4/31 (12.9%)
    Eye disorders
    Photopsia2/31 (6.5%)
    Surgical and medical procedures
    Knee arthroplasty2/31 (6.5%)

    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/TitleClinical Project Lead, GCRA, Surgical
    OrganizationAlcon Research, Ltd.
    Phone1-888-451-3937
    Emailalcon.medinfo@alcon.com
    Responsible Party:
    Alcon Research
    ClinicalTrials.gov Identifier:
    NCT02176343
    Other Study ID Numbers:
    • C-14-005
    First Posted:
    Jun 27, 2014
    Last Update Posted:
    Jul 2, 2018
    Last Verified:
    May 1, 2017