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Clinical Investigation of Corneal Incision Size After Intraocular Lens (IOL) Implantation

Primary Purpose

Cataracts

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
UltraSert Preloaded Delivery System
iTec Preloaded Delivery System
iSert Preloaded Delivery System
Monarch III D Manual IOL Delivery System
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

Inclusion Criteria:

  • Able to comprehend and sign a statement of informed consent;
  • Willing and able to complete all required postoperative visits;
  • Cataract;
  • Planned cataract removal by phacoemulsification;
  • Calculated lens power from 18.0 through 27.0 D inclusive;
  • Preoperative astigmatism <1.0D;
  • Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

  • Systemic disease that affects the cornea;
  • Any inflammation or edema of the cornea;
  • Previous or planned refractive or corneal surgery during the subject's participation in the study;
  • Previous corneal transplant;
  • Previous retinal detachment;
  • Pregnancy or lactation, current or planned, during the course of the study;
  • Current participation in another investigational drug or device study that may confound the results of this investigation;
  • Any condition observed before or during surgery that in the surgeon's medical opinion may affect the success of the cataract surgery;
  • Other protocol-specified exclusion criteria may apply.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    UltraSert Preloaded Delivery System

    iTec Preloaded Delivery System

    iSert Preloaded Delivery System

    Monarch III D Manual IOL Delivery System

    Arm Description

    Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery

    Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery

    Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery

    Manually loaded IOL delivered via a 2.4 mm clear corneal incision during cataract surgery

    Outcomes

    Primary Outcome Measures

    Mean Corneal Incision Size After IOL Implantation (UltraSert, iTec, and iSert)
    Post-IOL implantation corneal incision size was measured directly after IOL implantation and reported in millimeters (mm). Minimizing enlargement of incision size during cataract surgery results in less postoperative inflammation, less surgically-induced astigmatism, and more rapid visual and wound rehabilitation. This endpoint was prespecified for the UltraSert, iTec, and iSert preloaded delivery systems. Only one eye (study eye) contributed to the analysis.

    Secondary Outcome Measures

    Mean Corneal Incision Size After IOL Implantation (UltraSert and Monarch III D)
    Post-IOL implantation corneal incision size was measured directly after IOL implantation and reported in millimeters (mm). Minimizing enlargement of incision size during cataract surgery results in less postoperative inflammation, less surgically-induced astigmatism, and more rapid visual and wound rehabilitation. This endpoint was prespecified for the UltraSert preloaded delivery system and the Monarch III D delivery system. Only one eye (study eye) contributed to the analysis.

    Full Information

    First Posted
    July 5, 2016
    Last Updated
    May 31, 2018
    Sponsor
    Alcon Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02826421
    Brief Title
    Clinical Investigation of Corneal Incision Size After Intraocular Lens (IOL) Implantation
    Official Title
    Clinical Investigation of Corneal Incision Size After IOL Implantation With Preloaded Delivery Devices and a Manual Delivery Device
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    July 4, 2016 (Actual)
    Primary Completion Date
    November 29, 2016 (Actual)
    Study Completion Date
    November 29, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Alcon Research

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to compare corneal incision size after IOL implantation with the use of one of four IOL delivery systems (three preloaded IOL delivery systems and one manually loaded IOL delivery system).

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    114 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    UltraSert Preloaded Delivery System
    Arm Type
    Experimental
    Arm Description
    Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery
    Arm Title
    iTec Preloaded Delivery System
    Arm Type
    Active Comparator
    Arm Description
    Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery
    Arm Title
    iSert Preloaded Delivery System
    Arm Type
    Active Comparator
    Arm Description
    Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery
    Arm Title
    Monarch III D Manual IOL Delivery System
    Arm Type
    Active Comparator
    Arm Description
    Manually loaded IOL delivered via a 2.4 mm clear corneal incision during cataract surgery
    Intervention Type
    Device
    Intervention Name(s)
    UltraSert Preloaded Delivery System
    Intervention Description
    Includes AcrySof IQ monofocal posterior chamber IOL Model AU00T0, intended for long term use over the lifetime of the subject
    Intervention Type
    Device
    Intervention Name(s)
    iTec Preloaded Delivery System
    Intervention Description
    Includes TECNIS 1-piece monofocal IOL, intended for long term use over the lifetime of the subject
    Intervention Type
    Device
    Intervention Name(s)
    iSert Preloaded Delivery System
    Intervention Description
    Includes Model 251 or Model 250 posterior chamber IOL, as selected by the Investigator, intended for long term use over the lifetime of the subject
    Intervention Type
    Device
    Intervention Name(s)
    Monarch III D Manual IOL Delivery System
    Intervention Description
    Includes AcrySof IQ monofocal IOL posterior chamber IOL Model SN60WF, intended for long term use over the lifetime of the subject
    Primary Outcome Measure Information:
    Title
    Mean Corneal Incision Size After IOL Implantation (UltraSert, iTec, and iSert)
    Description
    Post-IOL implantation corneal incision size was measured directly after IOL implantation and reported in millimeters (mm). Minimizing enlargement of incision size during cataract surgery results in less postoperative inflammation, less surgically-induced astigmatism, and more rapid visual and wound rehabilitation. This endpoint was prespecified for the UltraSert, iTec, and iSert preloaded delivery systems. Only one eye (study eye) contributed to the analysis.
    Time Frame
    Day 0, operative day
    Secondary Outcome Measure Information:
    Title
    Mean Corneal Incision Size After IOL Implantation (UltraSert and Monarch III D)
    Description
    Post-IOL implantation corneal incision size was measured directly after IOL implantation and reported in millimeters (mm). Minimizing enlargement of incision size during cataract surgery results in less postoperative inflammation, less surgically-induced astigmatism, and more rapid visual and wound rehabilitation. This endpoint was prespecified for the UltraSert preloaded delivery system and the Monarch III D delivery system. Only one eye (study eye) contributed to the analysis.
    Time Frame
    Day 0, operative day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    22 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Able to comprehend and sign a statement of informed consent; Willing and able to complete all required postoperative visits; Cataract; Planned cataract removal by phacoemulsification; Calculated lens power from 18.0 through 27.0 D inclusive; Preoperative astigmatism <1.0D; Other protocol-specified inclusion criteria may apply. Exclusion Criteria: Systemic disease that affects the cornea; Any inflammation or edema of the cornea; Previous or planned refractive or corneal surgery during the subject's participation in the study; Previous corneal transplant; Previous retinal detachment; Pregnancy or lactation, current or planned, during the course of the study; Current participation in another investigational drug or device study that may confound the results of this investigation; Any condition observed before or during surgery that in the surgeon's medical opinion may affect the success of the cataract surgery; Other protocol-specified exclusion criteria may apply.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sr. Clinical Manager, GCRA
    Organizational Affiliation
    Alcon Research
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Clinical Investigation of Corneal Incision Size After Intraocular Lens (IOL) Implantation

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