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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Cataract; Intraocular Lens Implantation
• Intervention / Treatment: Procedure: FLA-CEIOL; Procedure: CEIOL

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of anterior vitrectomy	Of all cases in each group, what percent results in any complication that needed conversion to anterior vitrectomy	6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Southern California
• Collaborators: Alcon Research

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2017
• Primary Completion (Anticipated): July 1, 2018
• Study Completion (Anticipated): July 1, 2018

Study Registration Dates

• First Submitted: November 15, 2016
• First Submitted That Met QC Criteria: April 10, 2017
• First Posted (Actual): April 14, 2017

Study Record Updates

• Last Update Posted (Actual): September 24, 2019
• Last Update Submitted That Met QC Criteria: September 20, 2019
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: FLIRT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No