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IOP Changes Associated With SICS and Phako

Primary Purpose

Cataract, Glaucoma

Status
Completed
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
cataract surgery
Sponsored by
Robin, Alan L., M.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cataract

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:Age over 40 requiring cataract surgery -

Exclusion Criteria: inability to follow up, lens not suitable for phacoemulsification, prior intraocular surgery, glaucoma

-

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    phako

    MSICS

    Arm Description

    eyes receiving phakoemulsification for cataract surgery

    Eyes undergoing manual small incision cataract surgery

    Outcomes

    Primary Outcome Measures

    Intraocular pressure lowering
    intraocular pressure measured with aplanation tonometry

    Secondary Outcome Measures

    Angle anatomy
    OCT changes in angle anatomy

    Full Information

    First Posted
    December 19, 2015
    Last Updated
    January 5, 2016
    Sponsor
    Robin, Alan L., M.D.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02642211
    Brief Title
    IOP Changes Associated With SICS and Phako
    Official Title
    An Evaluation of Intraocular Pressure Reduction Following Phacoemulsification and Manual Small Incision Cataract Surgery: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2014 (undefined)
    Primary Completion Date
    September 2015 (Actual)
    Study Completion Date
    September 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Robin, Alan L., M.D.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Prospective randomized trial in patients requiring cataract surgery in which IOP, angle anatomy and other demographic and clinical data are compared. Subjects randomized to both MSICS and phakoemulsification
    Detailed Description
    Prospective, randomized, double masked, parallel assignment clincal trial. Five hundred eyes of 500 participants between 40 - 70 years with normal IOP, gonioscopically open angles and age related cataract. Eyes underwent phacoemulsification or MSICS following a 1:1 randomization and allocation code. Best corrected vision (BCVA), IOP, comprehensive slit lamp evaluation and anterior segment optical coherence tomography (ASOCT) were performed at baseline and at 1, 3 and 6 months follow up.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    500 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    phako
    Arm Type
    Active Comparator
    Arm Description
    eyes receiving phakoemulsification for cataract surgery
    Arm Title
    MSICS
    Arm Type
    Active Comparator
    Arm Description
    Eyes undergoing manual small incision cataract surgery
    Intervention Type
    Procedure
    Intervention Name(s)
    cataract surgery
    Intervention Description
    Eyes (one eye per patient) randomized to either phacoemulsification and intraocular lens insertion or small incision cataract surgery and intraocular lens insertion
    Primary Outcome Measure Information:
    Title
    Intraocular pressure lowering
    Description
    intraocular pressure measured with aplanation tonometry
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Angle anatomy
    Description
    OCT changes in angle anatomy
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria:Age over 40 requiring cataract surgery - Exclusion Criteria: inability to follow up, lens not suitable for phacoemulsification, prior intraocular surgery, glaucoma -

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    plan to share in paper form and at national meetings

    Learn more about this trial

    IOP Changes Associated With SICS and Phako

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