Clinical Trial: The Femtosecond Laser in Residency Training (FLIRT) Pilot Study

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: The Femtosecond Laser in Residency Training (FLIRT) Pilot Study: Femtosecond Laser-Assisted Versus Manual Cataract Extraction and Intraocular Lens Implantation

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.

Detailed Summary:
Sponsor: University of Southern California

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Incidence of dropped nucleus or intraocular lens (IOL) [ Time Frame: 6 months ]
    Complication when the nucleus or implanted intraocular lens falls posteriorly
  • Incidence of posterior capsular tear [ Time Frame: 6 months ]
    Complication where the posterior capsule is torn or ruptured
  • Incidence of anterior capsular tears or tags [ Time Frame: 6 months ]
    Complication where the anterior capsule is torn or ruptured
  • Incidence of zonal injury [ Time Frame: 6 months ]
    Complication where the cataractous nucleus or implanted IOL falls posteriorly.
  • Incidence of corneal injury [ Time Frame: 6 months ]
    Complication when the cornea is injured during surgery
  • 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
  • New onset ocular hypertension or glaucoma [ Time Frame: 6 months ]
    Ocular hypertension or glaucoma, which was not present before surgery
  • Postoperative outcomes such as uncorrected and best corrected distance visual acuity [ Time Frame: 6 months ]
    Measured by manifest refraction
  • Contrast sensitivity [ Time Frame: 6 months ]
    Measured by Pelli-Robson Contrast Sensitivity Chart and the Contrast Sensitivity Testing (CSV-1000E)
  • Spherical equivalent [ Time Frame: 6 months ]
    Calculated from the best corrected visual acuity
  • Corneal edema [ Time Frame: 6 months ]
    Graded by the surgeon on a scale of 0 to 3 (none, mild, moderate, severe)
  • Central corneal thickness [ Time Frame: 6 months ]
    Measured by pachymetry
  • Intraocular lens centration [ Time Frame: 6 months ]
    Subjectively graded by the surgeon on a scale of 0 to 4 (poor, average, fair, excellent centration).
  • Educational gains of the resident surgeon [ Time Frame: 6 months ]
    Done through surveys distributed to resident physicians throughout the course of the study


Original Secondary Outcome:

  • Incidence of dropped nucleus or intraocular lens [ Time Frame: 6 months ]
    Complication when the nucleus or implanted intraocular lens falls posteriorly
  • Incidence of posterior capsular tear [ Time Frame: 6 months ]
    Complication where the posterior capsule is torn or ruptured
  • Incidence of anterior capsular tears or tags [ Time Frame: 6 months ]
    Complication where the anterior capsule is torn or ruptured
  • Incidence of zonal injury [ Time Frame: 6 months ]
    Complication where the cataractous nuclus or implanted IOL falls posteriorly.
  • Incidence of corneal injury [ Time Frame: 6 months ]
    Complication when the cornea is injured during surgery
  • New onset macular edema [ Time Frame: 6 months ]
    Presence of macular edema, by clinical evaluation or OCT, which was not present before surgery
  • New onset ocular hypertension or glaucoma [ Time Frame: 6 months ]
    Ocular hypertension or glaucoma, which was not present before surgery
  • Postoperative outcomes such as uncorrected and best corrected distance visual acuity [ Time Frame: 6 months ]
    Measured by manifest refraction
  • Contrast sensitivity [ Time Frame: 6 months ]
    Measured by Pelli-Robson Contrast Sensitivity Chart and the CSV-1000E
  • Spherical equivalent [ Time Frame: 6 months ]
    Calculated from the best corrected visual acuity
  • Corneal edema [ Time Frame: 6 months ]
    Graded by the surgeon on a scale of 0 to 3 (none, mild, moderate, severe)
  • Central corneal thickness [ Time Frame: 6 months ]
    Measured by pachymetry
  • Intraocular lens centration [ Time Frame: 6 months ]
    Subjectively graded by the surgeon on a scale of 0 to 4 (poor, average, fair, excellent centration).
  • Educational gains of the resident surgeon [ Time Frame: 6 months ]
    Done through surveys distributed to resident physicians throughout the course of the study


Information By: University of Southern California

Dates:
Date Received: November 15, 2016
Date Started: July 2017
Date Completion: July 2018
Last Updated: April 17, 2017
Last Verified: April 2017