The Femtosecond Laser in Residency Training (FLIRT) Pilot... | NCT03115216

Studies
The Femtosecond Laser in Residency Training (FLIRT) Pilot Study

NCT03115216

Sponsor

University of Southern California

Status

Withdrawn

Last Update Posted

Sep 24, 2019Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Cataract
Intraocular Lens Implantation

Interventions

FLA-CEIOL
CEIOL

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

withdrawn during planning stages

Expanded Access Info

Start Date

Jul 2017Estimated

Primary Completion Date

Jul 2018Estimated

Completion Date

Jul 2018Estimated

First Submitted Date

Nov 15, 2016

First Submission Date that Met QC Criteria

Apr 10, 2017

First Posted Date

Apr 14, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 20, 2019

Last Update Posted Date

Sep 24, 2019Actual

Name	Class
Alcon Research	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
FLA-CEIOL	Active Comparator	Femtosecond laser assisted cataract extraction and intraocular lens placement	Procedure: FLA-CEIOL
CEIOL	Active Comparator	Clear corneal incision with manual cataract extraction and intraocular lens placement	Procedure: CEIOL

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FLA-CEIOL	Procedure	Femtosecond laser-assisted cataract extraction and intraocular lens placement	FLA-CEIOL

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases