The Femtosecond Laser in Residency Training (FLIRT) Pilot Study

NCT03115216 | Withdrawn

• 1 other identifier: FLIRT
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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 (14)

• Incidence of dropped nucleus or intraocular lens (IOL)

  6 months

• Incidence of posterior capsular tear

  6 months

• Incidence of anterior capsular tears or tags

  6 months

• Incidence of zonal injury

  6 months

• Incidence of corneal injury

  6 months

Study Arms (2)

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

FLA-CEIOL PROCEDURE

Femtosecond laser-assisted cataract extraction and intraocular lens placement

FLA-CEIOL

CEIOL PROCEDURE

Manual cataract extraction and intraocular lens placement

CEIOL

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead
• Alcon Research: collaborator

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2016
• First Posted: April 14, 2017
• Study Start: July 1, 2017
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: September 24, 2019

Record last verified: 2017-04