The Femtosecond Laser in Residency Training (FLIRT) Pilot Study

Cataract Clinical Trial

— FLIRT  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03115216
• Other study ID #: FLIRT
• Status: Withdrawn
• Phase: N/A
• Start date: July 2017
• Est. completion date: July 2018

Study information

• Verified date: April 2017
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Intraocular Lens Implantation

Intervention

Procedure:
• FLA-CEIOL
Femtosecond laser-assisted cataract extraction and intraocular lens placement
• CEIOL
Manual cataract extraction and intraocular lens placement

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	Alcon Research

Outcome

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