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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03115216
Recruitment Status : Withdrawn (withdrawn during planning stages)
First Posted : April 14, 2017
Last Update Posted : September 24, 2019
Sponsor:
Collaborator:
Alcon Research
Information provided by (Responsible Party):
University of Southern California

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.

Condition or disease Intervention/treatment Phase
Cataract Intraocular Lens Implantation Procedure: FLA-CEIOL Procedure: CEIOL Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Femtosecond Laser in Residency Training (FLIRT) Pilot Study: Femtosecond Laser-Assisted Versus Manual Cataract Extraction and Intraocular Lens Implantation
Estimated Study Start Date : July 2017
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
Active Comparator: FLA-CEIOL
Femtosecond laser assisted cataract extraction and intraocular lens placement
Procedure: FLA-CEIOL
Femtosecond laser-assisted cataract extraction and intraocular lens placement

Active Comparator: CEIOL
Clear corneal incision with manual cataract extraction and intraocular lens placement
Procedure: CEIOL
Manual cataract extraction and intraocular lens placement




Primary Outcome Measures :
  1. Incidence of anterior vitrectomy [ Time Frame: 6 months ]
    Of all cases in each group, what percent results in any complication that needed conversion to anterior vitrectomy


Secondary Outcome Measures :
  1. Incidence of dropped nucleus or intraocular lens (IOL) [ Time Frame: 6 months ]
    Complication when the nucleus or implanted intraocular lens falls posteriorly

  2. Incidence of posterior capsular tear [ Time Frame: 6 months ]
    Complication where the posterior capsule is torn or ruptured

  3. Incidence of anterior capsular tears or tags [ Time Frame: 6 months ]
    Complication where the anterior capsule is torn or ruptured

  4. Incidence of zonal injury [ Time Frame: 6 months ]
    Complication where the cataractous nucleus or implanted IOL falls posteriorly.

  5. Incidence of corneal injury [ Time Frame: 6 months ]
    Complication when the cornea is injured during surgery

  6. New onset macular edema [ Time Frame: 6 months ]
    Presence of macular edema, by clinical evaluation or optical coherence tomography (OCT), which was not present before surgery

  7. New onset ocular hypertension or glaucoma [ Time Frame: 6 months ]
    Ocular hypertension or glaucoma, which was not present before surgery

  8. Postoperative outcomes such as uncorrected and best corrected distance visual acuity [ Time Frame: 6 months ]
    Measured by manifest refraction

  9. Contrast sensitivity [ Time Frame: 6 months ]
    Measured by Pelli-Robson Contrast Sensitivity Chart and the Contrast Sensitivity Testing (CSV-1000E)

  10. Spherical equivalent [ Time Frame: 6 months ]
    Calculated from the best corrected visual acuity

  11. Corneal edema [ Time Frame: 6 months ]
    Graded by the surgeon on a scale of 0 to 3 (none, mild, moderate, severe)

  12. Central corneal thickness [ Time Frame: 6 months ]
    Measured by pachymetry

  13. Intraocular lens centration [ Time Frame: 6 months ]
    Subjectively graded by the surgeon on a scale of 0 to 4 (poor, average, fair, excellent centration).

  14. Educational gains of the resident surgeon [ Time Frame: 6 months ]
    Done through surveys distributed to resident physicians throughout the course of the study



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT03115216    
Other Study ID Numbers: FLIRT
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: September 24, 2019
Last Verified: April 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases