Resident-Performed Laser-Assisted vs Manual Traditional Phacoemulsification Cataract Surgery

Completed · Not applicable

Conditions studied: Incipient Cataract, Senile Nuclear Sclerosis

In brief

The study design will be a prospective study comparing laser-assisted cataract extraction cases and traditional manual phacoemulsification cases. All cases will be performed by faculty-supervised residents at Parkland Memorial Hospital. This study aims to examine visual acuity and complication rates in femtosecond laser-assisted cataract surgery compared to traditional manual phacoemulsification cataract surgery for the beginning surgeon. In addition, this study will assess the subjective novice surgeon experience and the patient experience in terms of expectations and results.

Key facts

Study ID

NCT02561104

Run by

University of Texas Southwestern Medical Center

People needed

148

Starts

2015-12-01

Expected to finish

2018-06-19

Last updated by the study team

2020-05-21

Who can join

Age: 21 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Referred for cataract surgery at Parkland Memorial Hospital
• Potential post-operative visual acuity of 20/30 or greater determined by potential acuity meter (PAM) testing or modified super pinhole potential acuity of 20/30 or greater
• Clear intraocular media other than cataract in study eye(s)
• Subject eyes will have a dilated pupil diameter of at least 6 mm
• Subject eyes will lack other pre-existing ocular pathology or condition that may confound treatment effects, including diabetic retinopathy, previous retinal detachment, iris neovascularization, amblyopia, optic nerve atrophy or recurrent severe anterior or posterior segment inflammation of unknown etiology.

You may not qualify if…

• Severe corneal diseases or prior corneal surgery
• Active, significant external ocular or eyelid disease
• History of lens abnormalities including posterior polar cataract and zonular weakness precluding standard non-complex cataract surgery
• Retinal or posterior segment disease
• Advanced glaucoma, white or advanced cataract (precluding adequate examination of the posterior pole)
• Anatomic conditions that prevent placement of the femtosecond laser docking ring
• Corneal opacity that will interfere with the laser beam (hazy cornea)
• Presence of blood or materials in the anterior chamber
• Hypotony, advanced glaucoma, or presence of cornea implant
• Poor dilating pupil such that the iris is not peripheral to the intended diameter for the capsulotomy
• Condition which would cause inadequate clearance between the intended capsulotomy depth and the corneal endothelium
• Any contraindication to cataract or kerato-refractive surgery
• Contact lens wearers must discontinue the use of contacts for an appropriate period of time to ensure that their corneas are stable before screening measurements are performed. For rigid gas permeable (RGP) lenses, it is at least 2-4 weeks before accurate imaging measurements can be performed. Study doctor will assess patient findings and determine how long RGP lens wear must be discontinued prior to surgery. For soft contact lenses, it is at least 3 days prior to study measurements.

Where it is running

• Parkland Memorial Hospital — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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