search
Back to results

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

Primary Purpose

Cataract, Aphakia

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Coaxial Micro-Incision Cataract Surgery
Coaxial Small Incision Cataract Surgery
Sponsored by
Bausch & Lomb Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring Ocular Surgery, Intraocular Lens

Eligibility Criteria

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

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Coaxial Micro-Incision Cataract Surgery

    Coaxial Small Incision Cataract Surgery

    Arm Description

    1.8 mm coaxial microincision

    2.75 mm standard incision

    Outcomes

    Primary Outcome Measures

    Refractive Stability
    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

    Best Corrected Visual Acuity
    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
    Best Corrected Visual Acuity
    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.
    Uncorrected Visual Acuity
    Uncorrected visual acuity(UCVA) was assessed using logMAR charts. Change from baseline summarized by visit.
    Uncorrected Visual Acuity
    Uncorrected visual acuity(UCVA) was assessed using logMAR charts. Change from baseline summarized by visit.
    Surgically Induced Astigmatism (SIA)
    Surgically induced astigmatism was presented in dioptres at each visit.
    Surgically Induced Astigmatism (SIA)
    Surgically induced astigmatism presented in dioptres at each visit.

    Full Information

    First Posted
    December 15, 2010
    Last Updated
    January 24, 2012
    Sponsor
    Bausch & Lomb Incorporated
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01261975
    Brief Title
    Co-Axial Micro-Incision Versus Co-Axial Small Incision Cataract Surgery Using the Stellaris Enhancement System
    Official Title
    Co-Axial Micro-incision Cataract Surgery(C-MICS) Versus Standard Co-Axial Small Incision Cataract Surgery Using the Stellaris Enhancement System
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2009 (undefined)
    Primary Completion Date
    April 2010 (Actual)
    Study Completion Date
    July 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Bausch & Lomb Incorporated

    4. Oversight

    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cataract, Aphakia
    Keywords
    Ocular Surgery, Intraocular Lens

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    36 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Coaxial Micro-Incision Cataract Surgery
    Arm Type
    Experimental
    Arm Description
    1.8 mm coaxial microincision
    Arm Title
    Coaxial Small Incision Cataract Surgery
    Arm Type
    Active Comparator
    Arm Description
    2.75 mm standard incision
    Intervention Type
    Procedure
    Intervention Name(s)
    Coaxial Micro-Incision Cataract Surgery
    Other Intervention Name(s)
    Stellaris Vision Enhancement System
    Intervention Description
    1.8 mm coaxial micro incision
    Intervention Type
    Procedure
    Intervention Name(s)
    Coaxial Small Incision Cataract Surgery
    Other Intervention Name(s)
    Stellaris Vision Enhancement System
    Intervention Description
    2.75 mm coaxial incision
    Primary Outcome Measure Information:
    Title
    Refractive Stability
    Description
    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.
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Best Corrected Visual Acuity
    Description
    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
    Time Frame
    Visit 1, visit 2, visit 3, visit 4
    Title
    Best Corrected Visual Acuity
    Description
    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.
    Time Frame
    visit 5, visit 6, visit 7, visit 8
    Title
    Uncorrected Visual Acuity
    Description
    Uncorrected visual acuity(UCVA) was assessed using logMAR charts. Change from baseline summarized by visit.
    Time Frame
    Visit 1, visit 2, visit 3, visit 4
    Title
    Uncorrected Visual Acuity
    Description
    Uncorrected visual acuity(UCVA) was assessed using logMAR charts. Change from baseline summarized by visit.
    Time Frame
    visit 5, visit 6, visit 7, visit 8
    Title
    Surgically Induced Astigmatism (SIA)
    Description
    Surgically induced astigmatism was presented in dioptres at each visit.
    Time Frame
    Visits 1-3
    Title
    Surgically Induced Astigmatism (SIA)
    Description
    Surgically induced astigmatism presented in dioptres at each visit.
    Time Frame
    Visits 4-8

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Anne Williart, MD
    Organizational Affiliation
    Bausch & Lomb Incorporated
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs