The Comparison of Cataract Lasers Using the Optimedica Catalys Laser and the Alcon LenSx Laser.

Steven H. Linn, OD

Status: Completed

Conditions: Nuclear Sclerosis of the Lens; Posterior Subcapsular Cataract; Cortical Cataract

Treatments: Procedure: Femtosecond Laser Assisted Cataract Surgery w/ LenSx Laser; Procedure: Femtosecond Laser Assisted Cataract Surgery w/ Catalys Laser

Study type: Interventional

Funder types: Other

Identifiers

NCT01878838

HV-AVO1

Details and patient eligibility

About

This study compares two FDA approved Cataract Lasers.

Full 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

Enrollment: 45 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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45 participants in 2 patient groups

Catalys Treated Eyes

Active Comparator group

Description:

Patient's aged 22 and older with visually significant cataracts undergoing Femtosecond Laser Assisted Cataract Surgery w/ Catalys Laser

Treatment:

Procedure: Femtosecond Laser Assisted Cataract Surgery w/ Catalys Laser

LenSx Treated Eyes

Active Comparator group

Description:

Patient's aged 22 and older with visually significant cataracts undergoing Femtosecond Laser Assisted Cataract Surgery w/ LenSx Laser.

Treatment:

Procedure: Femtosecond Laser Assisted Cataract Surgery w/ LenSx Laser

Sponsor of this trial

Lead Sponsor

Steven H. Linn, OD