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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03115216
Other study ID # FLIRT
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
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
Health authority
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Status Withdrawn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

Study Design


Related Conditions & MeSH terms


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
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