Status:
COMPLETED
The Comparison of Cataract Lasers Using the Optimedica Catalys Laser and the Alcon LenSx Laser.
Lead Sponsor:
Steven H. Linn, OD
Conditions:
Nuclear Sclerosis of the Lens
Posterior Subcapsular Cataract
Eligibility:
All Genders
22+ years
Phase:
NA
Brief Summary
This study compares two FDA approved Cataract Lasers.
Detailed Description
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 catara...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
- Pseudoexfoliation
- 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
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT01878838
Start Date
April 1 2013
End Date
January 1 2014
Last Update
March 11 2025
Active Locations (1)
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1
Hoopes Vision
Salt Lake City, Utah, United States, 84020