Clinical trial NCT03115216: The Femtosecond Laser in Residency Training (FLIRT) Pilot Study
Official title: The Femtosecond Laser in Residency Training (FLIRT) Pilot Study: Femtosecond Laser-Assisted Versus Manual Cataract Extraction and Intraocular Lens Implantation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cataract
Intraocular Lens Implantation
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: Alcon Research
First posted: 2017-04-14
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of anterior vitrectomy
timeFrame: 6 months
Secondary outcomes:
measure: Incidence of dropped nucleus or intraocular lens (IOL)
timeFrame: 6 months
measure: Incidence of posterior capsular tear
timeFrame: 6 months
measure: Incidence of anterior capsular tears or tags
timeFrame: 6 months
measure: Incidence of zonal injury
timeFrame: 6 months
measure: Incidence of corneal injury
timeFrame: 6 months
measure: New onset macular edema
timeFrame: 6 months
measure: New onset ocular hypertension or glaucoma
timeFrame: 6 months
measure: Postoperative outcomes such as uncorrected and best corrected distance visual acuity
timeFrame: 6 months
measure: Contrast sensitivity
timeFrame: 6 months
measure: Spherical equivalent
timeFrame: 6 months
measure: Corneal edema
timeFrame: 6 months
measure: Central corneal thickness
timeFrame: 6 months
measure: Intraocular lens centration
timeFrame: 6 months
measure: Educational gains of the resident surgeon
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References: