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A Comparison of Visual Function After Bilateral Implantation of Presbyopia-Correcting Intraocular Lenses (IOLs)

Sponsor
Alcon Research (Industry)
Overall Status
Completed
CT.gov ID
NCT01257217
Collaborator
(none)
31
Enrollment
2
Arms
7
Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate visual and refractive parameters in a series of subjects bilaterally implanted with presbyopia-correcting intraocular lenses (IOLs) during cataract surgery.

Condition or Disease Intervention/Treatment Phase
  • Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1
  • Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT
  • Device: Acri.LISA® 366D IOL
  • Device: Acri.LISA® 466TD Toric IOL
 N/A

Detailed Description

Each subject completed a preoperative examination of both eyes, implantation of IOL at the operative visit for each eye, and up to 4 postoperative visits (each eye examined at Day 1-2, with binocular visits at Month 1 and Month 3 after the second implantation). The second implantation occurred within 30 days of the first.

Study Design

Study Type:
Interventional
Actual Enrollment :
31 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
A Randomized, Subject-Masked Comparison of Visual Function After Bilateral Implantation of Presbyopia-Correcting IOLs
Study Start Date :
Nov 1, 2010
Actual Primary Completion Date :
Jun 1, 2011
Actual Study Completion Date :
Jun 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: ReSTOR +3

AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 or AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT, lens assignment and model determined by preoperative keratometric astigmatism, bilateral implantation

Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1
Multifocal IOL implanted for long-term use over the lifetime of the cataract patient

Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT
Multifocal IOL with extended secondary focal point and astigmatism correction implanted for long-term use over the lifetime of the cataract patient
Other Names:
  • Models SND1T2, SND1T3, SND1T4, SND1T5, SND1T6

    		•
    Active Comparator: Acri.LISA

    Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation

    Device: Acri.LISA® 366D IOL
    Aspheric diffractive IOL with +3.75 D add power implanted for long-term use over the lifetime of the cataract patient

    Device: Acri.LISA® 466TD Toric IOL
    Aspheric diffractive IOL with +3.75 D add power and astigmatism correction implanted for long-term use over the lifetime of the cataract patient

    Outcome Measures

    Primary Outcome Measures

    1. Mean Binocular Defocus VA at Month 3 [Month 3 from second eye implantation]

      Defocus VA (an indicator of the expected range of vision with a presbyopia-correcting IOL) was tested binocularly with the participant's best spectacle correction using a chart. Lenses of different spherical powers were placed in front of the eyes to produce varying levels of defocus. The VA at each spherical power 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

    1. Best Corrected Visual Acuity (BCVA) Across a Range of Distances at Month 3 [Month 3 from second eye implantation]

      Visual acuity (VA) was tested binocularly (both eyes together) with correction in place if needed across a range of distances under well-lit conditions using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts. 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.

    2. Uncorrected Visual Acuity Across a Range of Distances at Month 3 [Month 3 from second eye implantation]

      VA was tested binocularly unaided across a range of distances under well-lit conditions using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts. 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.

    3. Mean Refractive Spherical Equivalent at Month 3 [Month 3 from second eye implantation]

      A manifest refraction (vision check) was performed using a 100% contrast ETDRS chart under well-lit conditions. Results were documented for sphere, cylinder and axis readings. The refractive spherical equivalent was calculated according to the formula: sphere + ½ cylinder power. Both eyes contributed to the mean.

    4. Mean Radner Reading Speed [Month 3 from second eye implantation]

      Reading performance was measured using the Radner Reading Chart with no correction (without) and with best distance corrective aids (with). Reading speed was measured in words per minute.

    5. Patient Reported Outcomes at Month 3 [Month 3 from second eye implantation]

      The Visual Task Difficulty Assessment (VISTAS) questionnaire was completed by the subject to assess difficulty in completing everyday tasks that depend on good vision. Tasks were rated using a 1 to 5 point scale, where 1 = no difficulty; 2 = minor difficulty; 3 = moderate difficulty; 4 = major difficulty; 5 = cannot accomplish. Individual scores for each task were averaged to obtain the overall score for each vision type/function. Near vision was defined as less than 50 cm; intermediate vision as 50 cm to 1 m; extended intermediate vision as 90 cm to 4 m; and distant vision as more than 4 m.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Sign informed consent;

    • Able to attend postoperative examinations per protocol schedule;

    • Diagnosed with bilateral cataracts;

    • Planned cataract removal by phacoemulsification with implantation of an intraocular lens (IOL);

    • Preoperative astigmatism ≤ 2.5 diopter;

    • Good ocular health, with the exception of cataracts;

    • Free of disease(s)/condition(s) listed in the "Caution" section of the AcrySof IQ and Acri.LISA package inserts;

    • Able to undergo second eye surgery within one month of the first eye surgery;

    • Other protocol-defined inclusion criteria may apply.

    Exclusion Criteria:

    • Previous corneal surgery;

    • Planned multiple procedures during cataract/IOL implantation surgery;

    • Any ocular disease and/or condition that may compromise study results;

    • Pregnant or planning pregnancy during course of study;

    • History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.)

    • Diabetic retinopathy;

    • Macular degeneration;

    • History of retinal detachment;

    • Other protocol-defined exclusion criteria may apply.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Alcon Research

    Investigators

    • Study Director: Brand Lead, Surgical, Global Medical Affairs, Alcon Research

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alcon Research
    ClinicalTrials.gov Identifier:
    NCT01257217
    Other Study ID Numbers:
    • M09-051
    First Posted:
    Dec 9, 2010
    Last Update Posted:
    Jul 2, 2018
    Last Verified:
    Mar 1, 2017
    Keywords provided by Alcon Research
    Intraocular Lens
    Presbyopia
    multifocal
    Additional relevant MeSH terms:
    Cataract
    Presbyopia

    Study Results

    Participant Flow

    Recruitment Details Subjects were recruited from one investigative site located in Spain.
    Pre-assignment Detail Of the 31 enrolled participants, 1 exited prior to randomization due to withdrawn consent and 5 discontinued after randomization due to adverse event (1) and protocol deviation (4). This reporting group includes all randomized participants who received IOLs without major deviations and/or surgical complications (efficacy population).
    Arm/Group Title ReSTOR +3 Acri.LISA
    Arm/Group Description AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 or AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT, lens assignment and model determined by preoperative keratometric astigmatism, bilateral implantation Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation
    Period Title: Overall Study
    STARTED 15 10
    COMPLETED 13 10
    NOT COMPLETED 2 0

    Baseline Characteristics

    Arm/Group Title ReSTOR +3 Acri.LISA Total
    Arm/Group Description AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 or AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT, lens assignment and model determined by preoperative keratometric astigmatism, bilateral implantation Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation Total of all reporting groups
    Overall Participants 15 10 25
    Age, Customized (participants) [Number]
    < 21 years
    0
    0%
    0
    0%
    0
    0%
    ≥ 21 years
    15
    100%
    10
    100%
    25
    100%
    Sex: Female, Male (Count of Participants)
    Female
    9
    60%
    8
    80%
    17
    68%
    Male
    6
    40%
    2
    20%
    8
    32%
    Region of Enrollment (participants) [Number]
    Spain
    15
    100%
    10
    100%
    25
    100%

    Outcome Measures

    1. Primary Outcome
    Title Mean Binocular Defocus VA at Month 3
    Description Defocus VA (an indicator of the expected range of vision with a presbyopia-correcting IOL) was tested binocularly with the participant's best spectacle correction using a chart. Lenses of different spherical powers were placed in front of the eyes to produce varying levels of defocus. The VA at each spherical power 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 Month 3 from second eye implantation

    Outcome Measure Data

    Analysis Population Description
    This analysis population includes all subjects who received IOLs without major deviations and/or surgical complications.
    Arm/Group Title ReSTOR +3 Acri.LISA
    Arm/Group Description AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 or AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT, lens assignment and model determined by preoperative keratometric astigmatism, bilateral implantation Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation
    Measure Participants 13 10
    -5.00 diopter
    0.78
    (0.26)
    0.59
    (0.18)
    -4.50 diopter
    0.65
    (0.18)
    0.45
    (0.17)
    -4.00 diopter
    0.58
    (0.19)
    0.29
    (0.13)
    -3.50 diopter
    0.36
    (0.13)
    0.18
    (0.14)
    -3.00 diopter
    0.15
    (0.07)
    0.11
    (0.21)
    -2.50 diopter
    0.04
    (0.08)
    0.08
    (0.20)
    -2.00 diopter
    0.14
    (0.13)
    0.20
    (0.18)
    -1.50 diopter
    0.30
    (0.11)
    0.33
    (0.18)
    -1.00 diopter
    0.23
    (0.10)
    0.22
    (0.16)
    -0.50 diopter
    0.07
    (0.06)
    0.07
    (0.11)
    0.00 diopter
    -0.02
    (0.07)
    -0.05
    (0.14)
    +0.50 diopter
    0.06
    (0.08)
    0.06
    (0.18)
    +1.00 diopter
    0.26
    (0.11)
    0.21
    (0.16)
    +1.50 diopter
    0.54
    (0.21)
    0.37
    (0.19)
    +2.00 diopter
    0.63
    (0.23)
    0.51
    (0.16)
    2. Secondary Outcome
    Title Best Corrected Visual Acuity (BCVA) Across a Range of Distances at Month 3
    Description Visual acuity (VA) was tested binocularly (both eyes together) with correction in place if needed across a range of distances under well-lit conditions using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts. 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 Month 3 from second eye implantation

    Outcome Measure Data

    Analysis Population Description
    This analysis population includes all subjects who received IOLs without major deviations and/or surgical complications.
    Arm/Group Title ReSTOR +3 Acri.LISA
    Arm/Group Description AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 or AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT, lens assignment and model determined by preoperative keratometric astigmatism, bilateral implantation Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation
    Measure Participants 13 10
    Far distance 4 meters (m)
    -0.02
    (0.08)
    -0.05
    (0.15)
    Intermediate 70 centimeters (cm)
    0.39
    (0.11)
    0.35
    (0.09)
    Intermediate 60 cm
    0.33
    (0.10)
    0.35
    (0.09)
    Intermediate 50 cm
    0.24
    (0.11)
    0.28
    (0.11)
    Near 33/40 cm
    0.19
    (0.13)
    0.20
    (0.15)
    3. Secondary Outcome
    Title Uncorrected Visual Acuity Across a Range of Distances at Month 3
    Description VA was tested binocularly unaided across a range of distances under well-lit conditions using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts. 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 Month 3 from second eye implantation

    Outcome Measure Data

    Analysis Population Description
    This analysis population includes all subjects who received IOLs without major deviations and/or surgical complications.
    Arm/Group Title ReSTOR +3 Acri.LISA
    Arm/Group Description AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 or AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT, lens assignment and model determined by preoperative keratometric astigmatism, bilateral implantation Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation
    Measure Participants 13 10
    Far distance 4 meters (m)
    0.14
    (0.20)
    0.03
    (0.16)
    Intermediate 70 centimeters (cm)
    0.37
    (0.15)
    0.27
    (0.14)
    Intermediate 60 cm
    0.36
    (0.16)
    0.33
    (0.12)
    Intermediate 50 cm
    0.29
    (0.19)
    0.33
    (0.12)
    Near 33/40 cm
    0.27
    (0.18)
    0.28
    (0.12)
    4. Secondary Outcome
    Title Mean Refractive Spherical Equivalent at Month 3
    Description A manifest refraction (vision check) was performed using a 100% contrast ETDRS chart under well-lit conditions. Results were documented for sphere, cylinder and axis readings. The refractive spherical equivalent was calculated according to the formula: sphere + ½ cylinder power. Both eyes contributed to the mean.
    Time Frame Month 3 from second eye implantation

    Outcome Measure Data

    Analysis Population Description
    This analysis population includes all subjects who received IOLs without major deviations and/or surgical complications.
    Arm/Group Title ReSTOR +3 Acri.LISA
    Arm/Group Description AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 or AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT, lens assignment and model determined by preoperative keratometric astigmatism, bilateral implantation Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation
    Measure Participants 13 10
    Mean (Standard Deviation) [diopter]
    0.1
    (0.49)
    -0.3
    (0.49)
    5. Secondary Outcome
    Title Mean Radner Reading Speed
    Description Reading performance was measured using the Radner Reading Chart with no correction (without) and with best distance corrective aids (with). Reading speed was measured in words per minute.
    Time Frame Month 3 from second eye implantation

    Outcome Measure Data

    Analysis Population Description
    This analysis population includes all subjects who received IOLs without major deviations and/or surgical complications.
    Arm/Group Title ReSTOR +3/Without ReSTOR +3/With Acri.LISA/Without Acri.LISA/With
    Arm/Group Description AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 or AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, lens assignment and model determined by preoperative keratometric astigmatism, bilateral implantation, without corrective aids AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 or AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, lens assignment and model determined by preoperative keratometric astigmatism, bilateral implantation, with corrective aids Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation, without corrective aids Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation, with corrective aids
    Measure Participants 13 13 10 10
    Mean (Standard Deviation) [wpm]
    90.60
    (26.82)
    90.46
    (22.19)
    109.7
    (18.21)
    113.2
    (17.80)
    6. Secondary Outcome
    Title Patient Reported Outcomes at Month 3
    Description The Visual Task Difficulty Assessment (VISTAS) questionnaire was completed by the subject to assess difficulty in completing everyday tasks that depend on good vision. Tasks were rated using a 1 to 5 point scale, where 1 = no difficulty; 2 = minor difficulty; 3 = moderate difficulty; 4 = major difficulty; 5 = cannot accomplish. Individual scores for each task were averaged to obtain the overall score for each vision type/function. Near vision was defined as less than 50 cm; intermediate vision as 50 cm to 1 m; extended intermediate vision as 90 cm to 4 m; and distant vision as more than 4 m.
    Time Frame Month 3 from second eye implantation

    Outcome Measure Data

    Analysis Population Description
    This analysis population includes all subjects who received IOLs without major deviations and/or surgical complications.
    Arm/Group Title ReSTOR +3 Acri.LISA
    Arm/Group Description AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 or AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT, lens assignment and model determined by preoperative keratometric astigmatism, bilateral implantation Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation
    Measure Participants 13 10
    Near function scale score
    1.78
    (0.76)
    1.48
    (0.84)
    Intermediate function scale score
    1.13
    (0.18)
    1.19
    (0.38)
    Extended intermediate function scale score
    1.32
    (0.51)
    1.00
    (0.00)
    Distant function scale score
    1.08
    (0.13)
    1.04
    (0.10)

    Adverse Events

    Time Frame
    Adverse Event Reporting Description This analysis group includes all subjects who were randomized (N=17 for ReSTOR+3, N=13 for Acri.LISA) into the study.
    Arm/Group Title ReSTOR +3 Acri.LISA
    Arm/Group Description AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 or AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL
    All Cause Mortality
    ReSTOR +3 Acri.LISA
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    ReSTOR +3 Acri.LISA
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 2/17 (11.8%) 0/13 (0%)
    Eye disorders
    Macular oedema 1/17 (5.9%) 0/13 (0%)
    Posterior capsule rupture 1/17 (5.9%) 0/13 (0%)
    Other (Not Including Serious) Adverse Events
    ReSTOR +3 Acri.LISA
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 10/17 (58.8%) 1/13 (7.7%)
    Eye disorders
    Conjunctival haemorrhage 2/17 (11.8%) 0/13 (0%)
    Conjunctival hyperaemia 1/17 (5.9%) 0/13 (0%)
    Conjunctivitis 1/17 (5.9%) 0/13 (0%)
    Corneal oedema 5/17 (29.4%) 1/13 (7.7%)
    Corneal oedema/ocular hypertension 1/17 (5.9%) 0/13 (0%)
    Ocular hyperaemia/lacrimation 1/17 (5.9%) 0/13 (0%)
    Retinal cyst 1/17 (5.9%) 0/13 (0%)
    Investigations
    Intraocular pressure abnormal 1/17 (5.9%) 0/13 (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/Title Brand Lead, Surgical, Global Medical Affairs
    Organization Alcon Research, Ltd.
    Phone 1-888-451-3937
    Email alcon.medinfo@alcon.com
    Responsible Party:
    Alcon Research
    ClinicalTrials.gov Identifier:
    NCT01257217
    Other Study ID Numbers:
    • M09-051
    First Posted:
    Dec 9, 2010
    Last Update Posted:
    Jul 2, 2018
    Last Verified:
    Mar 1, 2017