Resident-Performed Laser-Assisted vs Manual Traditional Phacoemulsification Cataract Surgery (NCT02561104) | Clinical Trial Compass
CompletedNot Applicable
Resident-Performed Laser-Assisted vs Manual Traditional Phacoemulsification Cataract Surgery
United States148 participantsStarted 2015-12
Plain-language summary
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.
Who can participate
Age range21 Years – 99 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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
What they're measuring
1
Complication rates
Timeframe: Operative visit to last post-op visit at 3 mos
2
Visual Acuity
Timeframe: Change between baseline and 3 mos post-op.
Trial details
NCT IDNCT02561104
SponsorUniversity of Texas Southwestern Medical Center