The Femtosecond Laser in Residency Training (FLIRT) Pilot Study

Not Applicable

Withdrawn

• Conditions: Cataract; Intraocular Lens Implantation
• Interventions: Procedure: FLA-CEIOL; Procedure: CEIOL

• Registration Number: NCT03115216
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2016-11-15
• Status Verified: 2017-04
• Study First Submitted QC: 2017-04-10
• Study First Posted: 2017-04-14
• Study Start: 2017-07
• Primary Completion: 2018-07
• Study Completion: 2018-07
• Last Update Submitted: 2019-09-20
• Last Update Posted: 2019-09-24

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FLA-CEIOL	FLA-CEIOL	Femtosecond laser assisted cataract extraction and intraocular lens placement
CEIOL	CEIOL	Clear corneal incision with manual cataract extraction and intraocular lens placement

Primary Outcome Measures

Name	Time	Method
Incidence of anterior vitrectomy	6 months	Of all cases in each group, what percent results in any complication that needed conversion to anterior vitrectomy

Secondary Outcome Measures

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