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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Incidence of anterior vitrectomy
Of all cases in each group, what percent results in any complication that needed conversion to anterior vitrectomy
Time frame: 6 months
Incidence of dropped nucleus or intraocular lens (IOL)
Complication when the nucleus or implanted intraocular lens falls posteriorly
Time frame: 6 months
Incidence of posterior capsular tear
Complication where the posterior capsule is torn or ruptured
Time frame: 6 months
Incidence of anterior capsular tears or tags
Complication where the anterior capsule is torn or ruptured
Time frame: 6 months
Incidence of zonal injury
Complication where the cataractous nucleus or implanted IOL falls posteriorly.
Time frame: 6 months
Incidence of corneal injury
Complication when the cornea is injured during surgery
Time frame: 6 months
New onset macular edema
Presence of macular edema, by clinical evaluation or optical coherence tomography (OCT), which was not present before surgery
Time frame: 6 months
New onset ocular hypertension or glaucoma
Ocular hypertension or glaucoma, which was not present before surgery
Time frame: 6 months
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Postoperative outcomes such as uncorrected and best corrected distance visual acuity
Measured by manifest refraction
Time frame: 6 months
Contrast sensitivity
Measured by Pelli-Robson Contrast Sensitivity Chart and the Contrast Sensitivity Testing (CSV-1000E)
Time frame: 6 months
Spherical equivalent
Calculated from the best corrected visual acuity
Time frame: 6 months
Corneal edema
Graded by the surgeon on a scale of 0 to 3 (none, mild, moderate, severe)
Time frame: 6 months
Central corneal thickness
Measured by pachymetry
Time frame: 6 months
Intraocular lens centration
Subjectively graded by the surgeon on a scale of 0 to 4 (poor, average, fair, excellent centration).
Time frame: 6 months
Educational gains of the resident surgeon
Done through surveys distributed to resident physicians throughout the course of the study
Time frame: 6 months