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Intra and Postoperative Outcomes With 3 Injectors

Primary Purpose

Cataract

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Intraocular lens implantation
Autosert Injector
Royale Injector
Monarch III Injector
Sponsored by
Iladevi Cataract and IOL Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring Intraocular lens implantation

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients undergoing phacoemulsification for age-related uncomplicated cataracts through a 2.2mm incision.
  • Nuclear or corticonuclear of grade 2 to 4 according to the Lens Opacities Classification System (LOCS III)

Exclusion Criteria:

  • Glaucoma,
  • uveitis,
  • shallow anterior chamber (depth <2.1mm),
  • prior ocular trauma or surgery,
  • maximal pupillary dilatation <6mm,
  • high myopia (axial length >25mm),
  • posterior polar cataracts,
  • dense cataracts, and
  • an IOL power <19.0 D or >25.0 D

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Placebo Comparator

    Placebo Comparator

    Placebo Comparator

    Arm Label

    Autosert Group

    Royale Group

    Monarch III Injector

    Arm Description

    Procedure / Surgery : Intraocular lens implantation with Autosert injector

    Procedure / Surgery : Intraocular lens implantation with Royale Injector

    Procedure / Surgery : Intraocular lens implantation with Monarch III group

    Outcomes

    Primary Outcome Measures

    Incision enlargement in mm

    Secondary Outcome Measures

    Trypan Blue ingress into the anterior chamber in log units
    Incision morphology - qualitative

    Full Information

    First Posted
    June 2, 2015
    Last Updated
    June 8, 2015
    Sponsor
    Iladevi Cataract and IOL Research Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02466256
    Brief Title
    Intra and Postoperative Outcomes With 3 Injectors
    Official Title
    Comparison of Intraoperative Performance and Incision Morphology Using Three Injector Devices : Randomized, Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2013 (undefined)
    Primary Completion Date
    June 2014 (Actual)
    Study Completion Date
    June 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Iladevi Cataract and IOL Research Center

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This randomized clinical trial compares subjective performance during Intraocular lens (IOL) implantation, as well as incision enlargement and anterior segment morphology on OCT when IOL implantation was performed during microcoaxial phacoemulsification through a 2.2mm incision using one of three injectors : Manual screw type (Monarch III), Manual plunger type (Royale) and motorised injector (Autosert). Further, the investigators also looked at incision integrity by comparing ingress of trypan blue from the ocular surface into the anterior chamber.
    Detailed Description
    In this randomized, clinical trial, three types of injectors were compared : Manual, screw type injector (Monarch III) Manual, plunger type injector (Royale, ASICO) Motorized injector (Autosert, Alcon) Having performed a phacoemulsification through 2.2mm incision, IOL implantation was performed using a D cartridge and one of three injectors which was decided in a randomized fashion. The investigators evaluated incision enlargement at following points : at the end of phacoemulsification, and then, at the end of IOL implantation The investigators also looked at trypan blue ingress into the anterior chamber from the ocular surface. At 1 day, 1 week, and 1 month after surgery anterior segment OCT morphology was also studied. further, the surgeon was asked to subjectively grade the ease of implantation with each injector

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cataract
    Keywords
    Intraocular lens implantation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    120 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Autosert Group
    Arm Type
    Placebo Comparator
    Arm Description
    Procedure / Surgery : Intraocular lens implantation with Autosert injector
    Arm Title
    Royale Group
    Arm Type
    Placebo Comparator
    Arm Description
    Procedure / Surgery : Intraocular lens implantation with Royale Injector
    Arm Title
    Monarch III Injector
    Arm Type
    Placebo Comparator
    Arm Description
    Procedure / Surgery : Intraocular lens implantation with Monarch III group
    Intervention Type
    Procedure
    Intervention Name(s)
    Intraocular lens implantation
    Intervention Description
    Intraocular lens implantation
    Intervention Type
    Device
    Intervention Name(s)
    Autosert Injector
    Intervention Description
    Motorised injection device for intraocular lens implantation
    Intervention Type
    Device
    Intervention Name(s)
    Royale Injector
    Intervention Description
    Manual, plunger type injection device for intraocular lens implantation
    Intervention Type
    Device
    Intervention Name(s)
    Monarch III Injector
    Intervention Description
    Manual, screw type injection device for intraocular lens implantation
    Primary Outcome Measure Information:
    Title
    Incision enlargement in mm
    Time Frame
    1 minute after surgery
    Secondary Outcome Measure Information:
    Title
    Trypan Blue ingress into the anterior chamber in log units
    Time Frame
    1 minute after surgery
    Title
    Incision morphology - qualitative
    Time Frame
    1 day, 1 week and 1 month after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients undergoing phacoemulsification for age-related uncomplicated cataracts through a 2.2mm incision. Nuclear or corticonuclear of grade 2 to 4 according to the Lens Opacities Classification System (LOCS III) Exclusion Criteria: Glaucoma, uveitis, shallow anterior chamber (depth <2.1mm), prior ocular trauma or surgery, maximal pupillary dilatation <6mm, high myopia (axial length >25mm), posterior polar cataracts, dense cataracts, and an IOL power <19.0 D or >25.0 D
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    abhay r vasavada, ms, frcs
    Organizational Affiliation
    iladevi cataract & iol research centre
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Intra and Postoperative Outcomes With 3 Injectors

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