The Femtosecond Laser in Residency Training (FLIRT) Pilot Study

Study Overview
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Brief Summary
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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.

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

Conditions
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Cataract, Intraocular Lens Implantation

Intervention / Treatment
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* Procedure: FLA-CEIOL
* Procedure: CEIOL


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: FLA-CEIOL<br>Femtosecond laser assisted cataract extraction and intraocular lens placement | Procedure: FLA-CEIOL<br>* Femtosecond laser-assisted cataract extraction and intraocular lens placement<br>|
| Active Comparator: CEIOL<br>Clear corneal incision with manual cataract extraction and intraocular lens placement | Procedure: CEIOL<br>* Manual cataract extraction and intraocular lens placement<br>|

What is the study measuring?
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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 |