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CataractFLIRTNCT03115216

The Femtosecond Laser in Residency Training (FLIRT) Pilot Study

A study testing FLA-CEIOL and CEIOL in people with Cataract and Intraocular Lens Implantation, run by University of Southern California.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Cataract, Intraocular Lens Implantation
What is being tested?
FLA-CEIOL and CEIOL
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Jul 2017to Jul 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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)
Show all 18Show fewer
  • 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

About this study

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

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.

Being tested
FLA-CEIOL, CEIOL
Medical subject headings
Cataract

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FLA-CEIOLProcedure or surgery

    Femtosecond laser-assisted cataract extraction and intraocular lens placement

  • CEIOLProcedure or surgery

    Manual cataract extraction and intraocular lens placement

Study groups in NCT03115216
Study groupRoleWhat they receive
FLA-CEIOLActive comparatorFemtosecond laser assisted cataract extraction and intraocular lens placement
Receives: Procedure: FLA-CEIOL
CEIOLActive comparatorClear corneal incision with manual cataract extraction and intraocular lens placement
Receives: Procedure: CEIOL

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of anterior vitrectomy

    Of all cases in each group, what percent results in any complication that needed conversion to anterior vitrectomy

    Measured: 6 months

Secondary outcomes (14)

  1. Incidence of dropped nucleus or intraocular lens (IOL)

    Complication when the nucleus or implanted intraocular lens falls posteriorly

    Measured: 6 months

  2. Incidence of posterior capsular tear

    Complication where the posterior capsule is torn or ruptured

    Measured: 6 months

  3. Incidence of anterior capsular tears or tags

    Complication where the anterior capsule is torn or ruptured

    Measured: 6 months

  4. Incidence of zonal injury

    Complication where the cataractous nucleus or implanted IOL falls posteriorly.

    Measured: 6 months

  5. Incidence of corneal injury

    Complication when the cornea is injured during surgery

    Measured: 6 months

  6. New onset macular edema

    Presence of macular edema, by clinical evaluation or optical coherence tomography (OCT), which was not present before surgery

    Measured: 6 months

  7. New onset ocular hypertension or glaucoma

    Ocular hypertension or glaucoma, which was not present before surgery

    Measured: 6 months

  8. Postoperative outcomes such as uncorrected and best corrected distance visual acuity

    Measured by manifest refraction

    Measured: 6 months

  9. Contrast sensitivity

    Measured by Pelli-Robson Contrast Sensitivity Chart and the Contrast Sensitivity Testing (CSV-1000E)

    Measured: 6 months

  10. Spherical equivalent

    Calculated from the best corrected visual acuity

    Measured: 6 months

  11. Corneal edema

    Graded by the surgeon on a scale of 0 to 3 (none, mild, moderate, severe)

    Measured: 6 months

  12. Central corneal thickness

    Measured by pachymetry

    Measured: 6 months

  13. Intraocular lens centration

    Subjectively graded by the surgeon on a scale of 0 to 4 (poor, average, fair, excellent centration).

    Measured: 6 months

  14. Educational gains of the resident surgeon

    Done through surveys distributed to resident physicians throughout the course of the study

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2017
  2. Study startJul 2017 (estimated)
  3. Primary completionJul 2018 (estimated)
  4. Study completionJul 2018 (estimated)

Why it stopped: withdrawn during planning stages

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03115216
Sponsor's protocol ID
FLIRT
Acronym
FLIRT
Status last verified
Apr 2017
First submitted
15 Nov 2016
Last updated
24 Sep 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing FLA-CEIOL and CEIOL in people with Cataract and Intraocular Lens Implantation, run by University of Southern California.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 24 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of anterior vitrectomy (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03115216.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2019.

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