The Femtosecond Laser in Residency Training (FLIRT) Pilot Study: Femtosecond Laser-Assisted Versus Manual Cataract Extraction and Intraocular Lens Implantation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Primary Endpoint
- Incidence of anterior vitrectomy
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
CEIOL
Clear corneal incision with manual cataract extraction and intraocular lens placement
Intervention: CEIOL (Procedure)
FLA-CEIOL
Femtosecond laser assisted cataract extraction and intraocular lens placement
Intervention: FLA-CEIOL (Procedure)
Outcomes
Primary Outcomes
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 Outcomes
- Incidence of posterior capsular tear(6 months)
- Incidence of dropped nucleus or intraocular lens (IOL)(6 months)
- New onset ocular hypertension or glaucoma(6 months)
- Educational gains of the resident surgeon(6 months)
- New onset macular edema(6 months)
- Contrast sensitivity(6 months)
- Corneal edema(6 months)
- Incidence of anterior capsular tears or tags(6 months)
- Spherical equivalent(6 months)
- Incidence of zonal injury(6 months)
- Postoperative outcomes such as uncorrected and best corrected distance visual acuity(6 months)
- Central corneal thickness(6 months)
- Intraocular lens centration(6 months)
- Incidence of corneal injury(6 months)