Clinical trial NCT01878838: The Comparison of Cataract Lasers Using the Optimedica Catalys Laser and the Alcon LenSx Laser.
Official title: A Prospective Randomized Controlled Clinical Trial Comparing the Intra-operative Effects, Safety, Efficacy and Performance of Two Commercially Available Laser Systems in Patients Undergoing Femtosecond Laser-Assisted Cataract Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nuclear Sclerosis of the Lens
Posterior Subcapsular Cataract
Cortical Cataract
Lead sponsor: Hoopes Vision
Sponsor class: OTHER
First posted: 2013-06-17
Enrollment: 45
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 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 surgery.

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

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Cumulative Dissipated Energy
timeFrame: Intraoperative
Secondary outcomes:
measure: Complete Laser Capsulotomy
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Hoopes Vision
state: Utah
Study officials:
affiliation: Hoopes Vision
name: Robert P Rivera, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hoopes Vision
name: Steven H Linn, OD
role: STUDY_DIRECTOR
References:
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