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The Femtosecond Laser in Residency Training (FLIRT) Pilot Study (FLIRT)

Primary Purpose

Cataract, Intraocular Lens Implantation

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
FLA-CEIOL
CEIOL
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract

Eligibility Criteria

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

Inclusion Criteria:

  • Patients of the Los Angeles County + University of Southern California Medical Center (LAC+USC) who are 40 years or older with visually significant cataracts asking for surgical intervention.
  • Cataract must be visually and clinically significant on examination as determined by the resident surgeon and the attending physician.

Exclusion Criteria:

  • Age less than 40
  • Visual acuity 20/30 or better with refraction in the study eye
  • Any previous ocular surgery
  • Patient request for monovision or for correction at near at the expense of distance
  • Patient and physician decision to use an IOL implant other than monofocal IOL
  • Corneal pathology (e.g. Fuch's dystrophy, corneal opacity or scar, corneal ectasia)
  • Posterior or anterior capsular plaque
  • Posterior polar cataract
  • White cataract
  • Subluxated lens, weak zonules, or phacodonesis
  • Pseudoexfoliation syndrome
  • Failure of preoperative pupillary dilatation (< 6 mm dilation)
  • History of uveitis
  • History of retinal detachment
  • Untreated or active proliferative diabetic retinopathy
  • Untreated or active diabetic macular edema
  • Ocular diseases that may affect visual acuity or the operation (including and not limited to macular degeneration, retinitis pigmentosa, macular hole, advanced or end-stage glaucoma)
  • Neurological or systemic diseases that may affect visual acuity or the safety of the operation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    FLA-CEIOL

    CEIOL

    Arm Description

    Femtosecond laser assisted cataract extraction and intraocular lens placement

    Clear corneal incision with manual cataract extraction and intraocular lens placement

    Outcomes

    Primary Outcome Measures

    Incidence of anterior vitrectomy
    Of all cases in each group, what percent results in any complication that needed conversion to anterior vitrectomy

    Secondary Outcome Measures

    Incidence of dropped nucleus or intraocular lens (IOL)
    Complication when the nucleus or implanted intraocular lens falls posteriorly
    Incidence of posterior capsular tear
    Complication where the posterior capsule is torn or ruptured
    Incidence of anterior capsular tears or tags
    Complication where the anterior capsule is torn or ruptured
    Incidence of zonal injury
    Complication where the cataractous nucleus or implanted IOL falls posteriorly.
    Incidence of corneal injury
    Complication when the cornea is injured during surgery
    New onset macular edema
    Presence of macular edema, by clinical evaluation or optical coherence tomography (OCT), which was not present before surgery
    New onset ocular hypertension or glaucoma
    Ocular hypertension or glaucoma, which was not present before surgery
    Postoperative outcomes such as uncorrected and best corrected distance visual acuity
    Measured by manifest refraction
    Contrast sensitivity
    Measured by Pelli-Robson Contrast Sensitivity Chart and the Contrast Sensitivity Testing (CSV-1000E)
    Spherical equivalent
    Calculated from the best corrected visual acuity
    Corneal edema
    Graded by the surgeon on a scale of 0 to 3 (none, mild, moderate, severe)
    Central corneal thickness
    Measured by pachymetry
    Intraocular lens centration
    Subjectively graded by the surgeon on a scale of 0 to 4 (poor, average, fair, excellent centration).
    Educational gains of the resident surgeon
    Done through surveys distributed to resident physicians throughout the course of the study

    Full Information

    First Posted
    November 15, 2016
    Last Updated
    September 20, 2019
    Sponsor
    University of Southern California
    Collaborators
    Alcon Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03115216
    Brief Title
    The Femtosecond Laser in Residency Training (FLIRT) Pilot Study
    Acronym
    FLIRT
    Official Title
    The Femtosecond Laser in Residency Training (FLIRT) Pilot Study: Femtosecond Laser-Assisted Versus Manual Cataract Extraction and Intraocular Lens Implantation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    withdrawn during planning stages
    Study Start Date
    July 2017 (Anticipated)
    Primary Completion Date
    July 2018 (Anticipated)
    Study Completion Date
    July 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Southern California
    Collaborators
    Alcon Research

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This pilot study aims to primarily assess the rate of complication of anterior vitrectomy for patients undergoing femtosecond laser-assisted (FLA) cataract extraction and intraocular lens placement (CEIOL) compared to manual CEIOL, when performed by resident physicians under direct attending supervision. In this pilot study, the investigators aim to assess what the incidence of anterior vitrectomy is for each group, in order to better understand the sample size needed to assess whether there is a difference between these two groups. Secondarily, it will gather preliminary data on safety and refractive outcomes for patients undergoing these interventions.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cataract, Intraocular Lens Implantation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    FLA-CEIOL
    Arm Type
    Active Comparator
    Arm Description
    Femtosecond laser assisted cataract extraction and intraocular lens placement
    Arm Title
    CEIOL
    Arm Type
    Active Comparator
    Arm Description
    Clear corneal incision with manual cataract extraction and intraocular lens placement
    Intervention Type
    Procedure
    Intervention Name(s)
    FLA-CEIOL
    Intervention Description
    Femtosecond laser-assisted cataract extraction and intraocular lens placement
    Intervention Type
    Procedure
    Intervention Name(s)
    CEIOL
    Intervention Description
    Manual cataract extraction and intraocular lens placement
    Primary Outcome Measure Information:
    Title
    Incidence of anterior vitrectomy
    Description
    Of all cases in each group, what percent results in any complication that needed conversion to anterior vitrectomy
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Incidence of dropped nucleus or intraocular lens (IOL)
    Description
    Complication when the nucleus or implanted intraocular lens falls posteriorly
    Time Frame
    6 months
    Title
    Incidence of posterior capsular tear
    Description
    Complication where the posterior capsule is torn or ruptured
    Time Frame
    6 months
    Title
    Incidence of anterior capsular tears or tags
    Description
    Complication where the anterior capsule is torn or ruptured
    Time Frame
    6 months
    Title
    Incidence of zonal injury
    Description
    Complication where the cataractous nucleus or implanted IOL falls posteriorly.
    Time Frame
    6 months
    Title
    Incidence of corneal injury
    Description
    Complication when the cornea is injured during surgery
    Time Frame
    6 months
    Title
    New onset macular edema
    Description
    Presence of macular edema, by clinical evaluation or optical coherence tomography (OCT), which was not present before surgery
    Time Frame
    6 months
    Title
    New onset ocular hypertension or glaucoma
    Description
    Ocular hypertension or glaucoma, which was not present before surgery
    Time Frame
    6 months
    Title
    Postoperative outcomes such as uncorrected and best corrected distance visual acuity
    Description
    Measured by manifest refraction
    Time Frame
    6 months
    Title
    Contrast sensitivity
    Description
    Measured by Pelli-Robson Contrast Sensitivity Chart and the Contrast Sensitivity Testing (CSV-1000E)
    Time Frame
    6 months
    Title
    Spherical equivalent
    Description
    Calculated from the best corrected visual acuity
    Time Frame
    6 months
    Title
    Corneal edema
    Description
    Graded by the surgeon on a scale of 0 to 3 (none, mild, moderate, severe)
    Time Frame
    6 months
    Title
    Central corneal thickness
    Description
    Measured by pachymetry
    Time Frame
    6 months
    Title
    Intraocular lens centration
    Description
    Subjectively graded by the surgeon on a scale of 0 to 4 (poor, average, fair, excellent centration).
    Time Frame
    6 months
    Title
    Educational gains of the resident surgeon
    Description
    Done through surveys distributed to resident physicians throughout the course of the study
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients of the Los Angeles County + University of Southern California Medical Center (LAC+USC) who are 40 years or older with visually significant cataracts asking for surgical intervention. Cataract must be visually and clinically significant on examination as determined by the resident surgeon and the attending physician. Exclusion Criteria: Age less than 40 Visual acuity 20/30 or better with refraction in the study eye Any previous ocular surgery Patient request for monovision or for correction at near at the expense of distance Patient and physician decision to use an IOL implant other than monofocal IOL Corneal pathology (e.g. Fuch's dystrophy, corneal opacity or scar, corneal ectasia) Posterior or anterior capsular plaque Posterior polar cataract White cataract Subluxated lens, weak zonules, or phacodonesis Pseudoexfoliation syndrome Failure of preoperative pupillary dilatation (< 6 mm dilation) History of uveitis History of retinal detachment Untreated or active proliferative diabetic retinopathy Untreated or active diabetic macular edema Ocular diseases that may affect visual acuity or the operation (including and not limited to macular degeneration, retinitis pigmentosa, macular hole, advanced or end-stage glaucoma) Neurological or systemic diseases that may affect visual acuity or the safety of the operation

    12. IPD Sharing Statement

    Learn more about this trial

    The Femtosecond Laser in Residency Training (FLIRT) Pilot Study

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