Co-Axial Micro-Incision Versus Co-Axial Small Incision Cataract Surgery Using the Stellaris Enhancement System

Sponsor
Bausch & Lomb Incorporated (Industry)
Overall Status
Completed
CT.gov ID
NCT01261975
Collaborator
(none)
36
Enrollment
2
Arms
11
Duration (Months)

Study Details

Study Description

Brief Summary

The objective of this study is to test the hypothesis that the time to reach a stable refraction is significantly shorter in eyes operated with the 1.8 mm coaxial microincision compared to eyes operated with the 2.75 mm standard incision using the Stellaris Vision Enhancement System.

Condition or DiseaseIntervention/TreatmentPhase
  • Procedure: Coaxial Micro-Incision Cataract Surgery
  • Procedure: Coaxial Small Incision Cataract Surgery
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Co-Axial Micro-incision Cataract Surgery(C-MICS) Versus Standard Co-Axial Small Incision Cataract Surgery Using the Stellaris Enhancement System
Study Start Date :
Aug 1, 2009
Actual Primary Completion Date :
Apr 1, 2010
Actual Study Completion Date :
Jul 1, 2010

Arms and Interventions

ArmIntervention/Treatment
Experimental: Coaxial Micro-Incision Cataract Surgery

1.8 mm coaxial microincision

Procedure: Coaxial Micro-Incision Cataract Surgery
1.8 mm coaxial micro incision
Other Names:
  • Stellaris Vision Enhancement System
  • Active Comparator: Coaxial Small Incision Cataract Surgery

    2.75 mm standard incision

    Procedure: Coaxial Small Incision Cataract Surgery
    2.75 mm coaxial incision
    Other Names:
  • Stellaris Vision Enhancement System
  • Outcome Measures

    Primary Outcome Measures

    1. Refractive Stability [12 weeks]

      Cumulative portion of eyes achieving refractive stability within 0.5 D of the final value for the remainder of the trial by surgical procedure and visit.

    Secondary Outcome Measures

    1. Best Corrected Visual Acuity [Visit 1, visit 2, visit 3, visit 4]

      Best corrected distance visual acuity(BCVA) was assessed using logMAR charts. Change from preoperative visit summarized by visit. A minus change represents an improvement of the visual acuity

    2. Best Corrected Visual Acuity [visit 5, visit 6, visit 7, visit 8]

      Best corrected distance visual acuity(BCVA) was assessed using logMAR charts. Change from baseline summarized by visit. A minus change represents an improvement of the visual acuity.

    3. Uncorrected Visual Acuity [Visit 1, visit 2, visit 3, visit 4]

      Uncorrected visual acuity(UCVA) was assessed using logMAR charts. Change from baseline summarized by visit.

    4. Uncorrected Visual Acuity [visit 5, visit 6, visit 7, visit 8]

      Uncorrected visual acuity(UCVA) was assessed using logMAR charts. Change from baseline summarized by visit.

    5. Surgically Induced Astigmatism (SIA) [Visits 1-3]

      Surgically induced astigmatism was presented in dioptres at each visit.

    6. Surgically Induced Astigmatism (SIA) [Visits 4-8]

      Surgically induced astigmatism presented in dioptres at each visit.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Subjects must be undergoing bilateral primary in-the-bag intraocular lens (IOL) implantation for the correction of aphakia.

    • Subject's ocular media must be clear except for the presence of the cataract in both eyes.

    Exclusion Criteria:
    • Subject with any disease, which, in the Investigator's opinion, might interfere with the conduct of the study.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Bausch & Lomb Incorporated

    Investigators

    • Study Director: Anne Williart, MD, Bausch & Lomb Incorporated

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bausch & Lomb Incorporated
    ClinicalTrials.gov Identifier:
    NCT01261975
    Other Study ID Numbers:
    • 607
    First Posted:
    Dec 17, 2010
    Last Update Posted:
    Feb 27, 2012
    Last Verified:
    Jan 1, 2012
    Keywords provided by Bausch & Lomb Incorporated
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment DetailsThis study was conducted at one clinical site in Europe. First participant was enrolled on 8/25/2009 and last participant exited the study on 4/27/2010. Study lasted six months for enrollment and three months for follow-up.
    Pre-assignment Detail36 participants at least 50 years of age were enrolled in bilateral cataract surgery with phacoemulsification and intraocular lens implantation for the correction of aphakia. The Stellaris Vision Enhancement System was used for a 1.8mm Coaxial Micro-Incision procedure in one eye and a 2.75mm coaxial standard procedure in the contralateral eye.
    Arm/Group TitleCataract Surgery
    Arm/Group DescriptionCataract surgery with phacoemulsification. Eligible patients were randomized to undergo cataract surgery using the 1.8 mm coaxial micro incision technique in either the right eye or the left eye. The fellow eye was assigned to undergo cataract surgery using the 2.75 mm standard incision. The Stellaris Vision Enhancement System was used for the surgery.
    Period Title: Overall Study
    STARTED36
    COMPLETED35
    NOT COMPLETED1

    Baseline Characteristics

    Arm/Group TitleCataract Surgery
    Arm/Group DescriptionCataract surgery with phacoemulsification using the Stellaris Vision Enhancement System
    Overall Participants36
    Age, Customized (participants) [Number]
    Aged 71 to 81 years
    36
    100%
    Sex: Female, Male (Count of Participants)
    Female
    25
    69.4%
    Male
    11
    30.6%
    Region of Enrollment (participants) [Number]
    Europe
    36
    100%

    Outcome Measures

    1. Primary Outcome
    TitleRefractive Stability
    DescriptionCumulative portion of eyes achieving refractive stability within 0.5 D of the final value for the remainder of the trial by surgical procedure and visit.
    Time Frame12 weeks

    Outcome Measure Data

    Analysis Population Description
    Cumulative Proportion of Eyes Achieving Refractive Stability (within 0.5 D)- Full analysis Set (FAS) Population
    Arm/Group TitleCoaxial Micro-Incision Cataract SurgeryCoaxial Small-Incision Cataract Surgery
    Arm/Group Description1.8 mm coaxial micro-incision cataract surgery (C-MICS) with phacoemulsification using the Stellaris Vision Enhancement System2.75 mm coaxial standard cataract surgical procedure with phacoemulsification using the Stellaris Vision Enhancement System.
    Measure Participants3635
    Measure eyes3635
    Visit 1
    17
    23
    Visit 2
    25
    25
    Visit 3
    27
    27
    Visit 4
    27
    28
    Visit 5
    28
    30
    Visit 6
    29
    31
    Visit 7
    29
    33
    2. Secondary Outcome
    TitleBest Corrected Visual Acuity
    DescriptionBest corrected distance visual acuity(BCVA) was assessed using logMAR charts. Change from preoperative visit summarized by visit. A minus change represents an improvement of the visual acuity
    Time FrameVisit 1, visit 2, visit 3, visit 4

    Outcome Measure Data

    Analysis Population Description
    Best Corrected Distance Visual Acuity (logMAR), Change from baseline, FAS Population
    Arm/Group TitleCoaxial Micro-Incision Cataract SurgeryCoaxial Small-Incision Cataract Surgery
    Arm/Group Description1.8 mm coaxial micro-incision cataract surgery (C-MICS) with phacoemulsification using the Stellaris Vision Enhancement System2.75 mm coaxial standard cataract surgical procedure with phacoemulsification using the Stellaris Vision Enhancement System.
    Measure Participants3635
    Measure eyes3635
    Visit 1
    -0.26
    (0.24)
    -0.27
    (0.29)
    Visit 2
    -0.37
    (0.22)
    -0.39
    (0.26)
    Visit 3
    -0.38
    (0.20)
    -0.38
    (0.27)
    Visit 4
    -0.39
    (0.24)
    -0.38
    (0.27)
    3. Secondary Outcome
    TitleBest Corrected Visual Acuity
    DescriptionBest corrected distance visual acuity(BCVA) was assessed using logMAR charts. Change from baseline summarized by visit. A minus change represents an improvement of the visual acuity.
    Time Framevisit 5, visit 6, visit 7, visit 8

    Outcome Measure Data

    Analysis Population Description
    Best Corrected Distance Visual Acuity (logMAR), change from baseline, FAS Population
    Arm/Group TitleCoaxial Micro-Incision Cataract SurgeryCoaxial Small-Incision Cataract Surgery
    Arm/Group Description1.8 mm coaxial micro-incision cataract surgery (C-MICS) with phacoemulsification using the Stellaris Vision Enhancement System2.75 mm coaxial standard cataract surgical procedure with phacoemulsification using the Stellaris Vision Enhancement System.
    Measure Participants3535
    Measure eyes3535
    Visit 5
    -0.40
    (0.22)
    -0.40
    (0.27)
    Visit 6
    -0.39
    (0.24)
    -0.42
    (0.27)
    Visit 7
    -0.40
    (0.24)
    -0.42
    (0.26)
    Visit 8
    -0.41
    (0.22)
    -0.41
    (0.28)
    4. Secondary Outcome
    TitleUncorrected Visual Acuity
    DescriptionUncorrected visual acuity(UCVA) was assessed using logMAR charts. Change from baseline summarized by visit.
    Time FrameVisit 1, visit 2, visit 3, visit 4

    Outcome Measure Data

    Analysis Population Description
    Uncorrected Visual Acuity (logMAR), change from baseline, FAS Population
    Arm/Group TitleCoaxial Micro-Incision Cataract SurgeryCoaxial Small-Incision Cataract Surgery
    Arm/Group Description1.8 mm coaxial micro-incision cataract surgery (C-MICS) with phacoemulsification using the Stellaris Vision Enhancement System2.75 mm coaxial standard cataract surgical procedure with phacoemulsification using the Stellaris Vision Enhancement System.
    Measure Participants3635
    Measure eyes3635
    Visit 1
    -0.22
    (0.32)
    -0.34
    (0.31)
    Visit 2
    -0.37
    (0.29)
    -0.45
    (0.31)
    Visit 3
    -0.37
    (0.30)
    -0.41
    (0.32)
    Visit 4
    -0.36
    (0.30)
    -0.46
    (0.31)
    5. Secondary Outcome
    TitleUncorrected Visual Acuity
    DescriptionUncorrected visual acuity(UCVA) was assessed using logMAR charts. Change from baseline summarized by visit.
    Time Framevisit 5, visit 6, visit 7, visit 8

    Outcome Measure Data

    Analysis Population Description
    Uncorrected Visual Acuity (logMAR), change from baseline, FAS Population
    Arm/Group TitleCoaxial Micro-Incision Cataract SurgeryCoaxial Small-Incision Cataract Surgery
    Arm/Group Description1.8 mm coaxial micro-incision cataract surgery (C-MICS) with phacoemulsification using the Stellaris Vision Enhancement System2.75 mm coaxial standard cataract surgical procedure with phacoemulsification using the Stellaris Vision Enhancement System.
    Measure Participants3535
    Measure eyes3535
    Visit 5
    -0.36
    (0.33)
    -0.48
    (0.32)
    Visit 6
    -0.35
    (0.31)
    -0.47
    (0.34)
    Visit 7
    -0.36
    (0.35)
    -0.49
    (0.33)
    Visit 8
    -0.38
    (0.31)
    -0.51
    (0.32)
    6. Secondary Outcome
    TitleSurgically Induced Astigmatism (SIA)
    DescriptionSurgically induced astigmatism was presented in dioptres at each visit.
    Time FrameVisits 1-3

    Outcome Measure Data

    Analysis Population Description
    Surgically Induced Astigmatism, FAS Population
    Arm/Group TitleCoaxial Micro-Incision Cataract SurgeryCoaxial Small-Incision Cataract Surgery
    Arm/Group Description1.8 mm coaxial micro-incision cataract surgery (C-MICS) with phacoemulsification using the Stellaris Vision Enhancement System2.75 mm coaxial standard cataract surgical procedure with phacoemulsification using the Stellaris Vision Enhancement System.
    Measure Participants3635
    Measure eyes3635
    Visit 1
    0.70
    (0.55)
    0.80
    (0.49)
    Visit 2
    0.45
    (0.39)
    0.61
    (0.33)
    Visit 3
    0.41
    (0.21)
    0.60
    (0.31)
    7. Secondary Outcome
    TitleSurgically Induced Astigmatism (SIA)
    DescriptionSurgically induced astigmatism presented in dioptres at each visit.
    Time FrameVisits 4-8

    Outcome Measure Data

    Analysis Population Description
    Surgically Induced Astigmatism-FAS Population
    Arm/Group TitleCoaxial Micro-Incision Cataract SurgeryCoaxial Small-Incision Cataract Surgery
    Arm/Group Description1.8 mm coaxial micro-incision cataract surgery (C-MICS) with phacoemulsification using the Stellaris Vision Enhancement System2.75 mm coaxial standard cataract surgical procedure with phacoemulsification using the Stellaris Vision Enhancement System.
    Measure Participants3535
    Measure eyes3535
    Visit 4
    0.44
    (0.37)
    0.52
    (0.31)
    Visit 5
    0.39
    (0.36)
    0.53
    (0.35)
    Visit 6
    0.37
    (0.27)
    0.59
    (0.30)
    Visit 7
    0.37
    (0.31)
    0.51
    (0.31)
    Visit 8
    0.37
    (0.21)
    0.42
    (0.26)

    Adverse Events

    Time Frame12 Weeks
    Adverse Event Reporting Description Safety Set
    Arm/Group TitleCo-Axial Micro-Incision Cataract SurgeryCoaxial Small-Incision Cataract SurgeryCataract Surgery All Participants
    Arm/Group Description1.8 mm coaxial micro-incision cataract surgery (C-MICS) with phacoemulsification using the Stellaris Vision Enhancement System.2.75 mm coaxial standard cataract surgical procedure with phacoemulsification using the Stellaris Vision Enhancement System.Events by participant one eye with 1.8 mm coaxial micro-incision cataract surgery (C-MICS) and the contralateral eye with the 2.75 mm coaxial standard cataract surgery.
    All Cause Mortality
    Co-Axial Micro-Incision Cataract SurgeryCoaxial Small-Incision Cataract SurgeryCataract Surgery All Participants
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total/ (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Co-Axial Micro-Incision Cataract SurgeryCoaxial Small-Incision Cataract SurgeryCataract Surgery All Participants
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total1/36 (2.8%) 0/35 (0%) 5/36 (13.9%)
    Eye disorders
    Macular Degeneration1/36 (2.8%) 10/35 (0%) 00/36 (0%) 0
    Infections and infestations
    Erysipelas0/36 (0%) 00/35 (0%) 01/36 (2.8%) 1
    Musculoskeletal and connective tissue disorders
    Hip Arthrosis0/36 (0%) 00/35 (0%) 01/36 (2.8%) 1
    Carpal Tunnel Syndrome0/36 (0%) 00/35 (0%) 01/36 (2.8%) 1
    Renal and urinary disorders
    Urinary Tract Infection0/36 (0%) 00/35 (0%) 01/36 (2.8%) 1
    Vascular disorders
    High Blood Pressure0/36 (0%) 00/35 (0%) 01/36 (2.8%) 1
    Other (Not Including Serious) Adverse Events
    Co-Axial Micro-Incision Cataract SurgeryCoaxial Small-Incision Cataract SurgeryCataract Surgery All Participants
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total33/36 (91.7%) 33/35 (94.3%) 66/71 (93%)
    Eye disorders
    Anterior Chamber Cell28/36 (77.8%) 3030/35 (85.7%) 3258/71 (81.7%) 62
    Corneal Edema21/36 (58.3%) 2122/35 (62.9%) 2243/71 (60.6%) 43
    Anterior Chamber flare8/36 (22.2%) 88/35 (22.9%) 916/71 (22.5%) 17
    Visual Disturbance4/36 (11.1%) 42/35 (5.7%) 26/71 (8.5%) 6
    Posterior Capsule Opacification2/36 (5.6%) 22/35 (5.7%) 24/71 (5.6%) 4
    Conjunctivitis2/36 (5.6%) 21/35 (2.9%) 13/71 (4.2%) 3
    Blurred Vision2/36 (5.6%) 21/35 (2.9%) 13/71 (4.2%) 3
    Vitreous Detachment2/36 (5.6%) 20/35 (0%) 02/71 (2.8%) 2
    Increased Intraocular Pressure5/36 (13.9%) 54/35 (11.4%) 49/71 (12.7%) 9

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

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

    All study data generated as a result of this study will be regarded as confidential, until appropriate analysis and review by the Sponsor or its designee and the Investigator(s) are completed. The results of the study may be published or presented by the Investigator(s) after the review by, and in consultation and agreement with the Sponsor, and such that confidential or proprietary information is not disclosed.

    Results Point of Contact

    Name/TitleOmid Khodai
    OrganizationBausch & Lomb
    Phone(949) 521-7894
    EmailOmid.Khodai@bausch.com
    Responsible Party:
    Bausch & Lomb Incorporated
    ClinicalTrials.gov Identifier:
    NCT01261975
    Other Study ID Numbers:
    • 607
    First Posted:
    Dec 17, 2010
    Last Update Posted:
    Feb 27, 2012
    Last Verified:
    Jan 1, 2012