The Femtosecond Laser in Residency Training (FLIRT) Pilot Study

NCT ID: NCT03115216

Last Updated: 2019-09-24

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-31
• Study Completion Date: 2018-07-31

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.

Conditions

Cataract; Intraocular Lens Implantation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

FLA-CEIOL

Femtosecond laser assisted cataract extraction and intraocular lens placement

Group Type: ACTIVE_COMPARATOR

FLA-CEIOL

Intervention Type: PROCEDURE

Femtosecond laser-assisted cataract extraction and intraocular lens placement

CEIOL

Clear corneal incision with manual cataract extraction and intraocular lens placement

Group Type: ACTIVE_COMPARATOR

CEIOL

Intervention Type: PROCEDURE

Manual cataract extraction and intraocular lens placement

Interventions

FLA-CEIOL

Femtosecond laser-assisted cataract extraction and intraocular lens placement

Intervention Type: PROCEDURE

CEIOL

Manual cataract extraction and intraocular lens placement

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: collaborator

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

FLIRT

Identifier Type: -

Identifier Source: org_study_id