Salt Lake City,
This study compares two FDA approved Cataract Lasers.
The purpose of this study is to systematically evaluate the performance of two commercially
available and FDA cleared femtosecond laser systems in patients undergoing femtosecond
laser-assisted cataract surgery. Objective data on the repeatability and accuracy of the
studied parameters will be gathered and reported as endpoints of the study.
The two systems studied are the Catalys™ Precision Laser System (OptiMedica, CA, USA) and
the LenSx® Laser System (Alcon Laboratories, Inc., Fort Worth, TX).
Published data have suggested that the femtosecond laser is a useful tool for cataract
This study is to determine whether differences or similarities exist in specific treatment
parameters achieved with two FDA cleared and commercially available femtosecond laser
cataract surgery platforms
- Have grade 2 to 4 nuclear sclerotic and or cortical or posterior subcapsular
cataracts with visual impairment.
- Pupillary dilation of at least 6.0 mm
- Axial length between 21 mm to 26 mm
- Age ≥ 22 years of either gender
- Require laser assisted corneal incisions, capsulotomy and nucleus segmentation
- Understand and sign a written Informed Consent form
- Be able to comply with the treatment and follow-up schedule
- Enrolment in another drug or device study within the prior 3 months
- History of ocular trauma
- Acute or chronic disease or illness that would increase risk or confound study
results (e.g., uncontrolled diabetes mellitus, immunocompromised, etc.)
- Uncontrolled systemic or ocular disease
- Corneal abnormalities (e.g., stromal, epithelial or endothelial dystrophies, severe
corneal opacities, significant corneal edema, etc)
- Diminished aqueous clarity that obscures OCT imaging of the anterior lens capsule
- Corneal ring and/or inlay implant(s)
- Known steroid IOP responder or ocular hypertension IOP >25 mmHg by tonometry
- Retinal detachment within the last 6 months
- Anterior chamber depth less than 2.5 mm