Cataract, Intraocular Lens Implantation
Conditions
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.
Interventions
PROCEDURECEIOL
Manual cataract extraction and intraocular lens placement
PROCEDUREFLA-CEIOL
Femtosecond laser-assisted cataract extraction and intraocular lens placement
Sponsors
Alcon Research
University of Southern California
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of anterior vitrectomy | 6 months | Of all cases in each group, what percent results in any complication that needed conversion to anterior vitrectomy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of posterior capsular tear | 6 months | Complication where the posterior capsule is torn or ruptured |
| Incidence of anterior capsular tears or tags | 6 months | Complication where the anterior capsule is torn or ruptured |
| Incidence of zonal injury | 6 months | Complication where the cataractous nucleus or implanted IOL falls posteriorly. |
| Incidence of corneal injury | 6 months | Complication when the cornea is injured during surgery |
| New onset macular edema | 6 months | Presence of macular edema, by clinical evaluation or optical coherence tomography (OCT), which was not present before surgery |
| New onset ocular hypertension or glaucoma | 6 months | Ocular hypertension or glaucoma, which was not present before surgery |
| Incidence of dropped nucleus or intraocular lens (IOL) | 6 months | Complication when the nucleus or implanted intraocular lens falls posteriorly |
| Contrast sensitivity | 6 months | Measured by Pelli-Robson Contrast Sensitivity Chart and the Contrast Sensitivity Testing (CSV-1000E) |
| Spherical equivalent | 6 months | Calculated from the best corrected visual acuity |
| Corneal edema | 6 months | Graded by the surgeon on a scale of 0 to 3 (none, mild, moderate, severe) |
| Central corneal thickness | 6 months | Measured by pachymetry |
| Intraocular lens centration | 6 months | Subjectively graded by the surgeon on a scale of 0 to 4 (poor, average, fair, excellent centration). |
| Educational gains of the resident surgeon | 6 months | Done through surveys distributed to resident physicians throughout the course of the study |
| Postoperative outcomes such as uncorrected and best corrected distance visual acuity | 6 months | Measured by manifest refraction |
Outcome results
None listed