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CompletedNCT01878838Updated Mar 11, 2025

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

An interventional study of Femtosecond Laser Assisted Cataract Surgery w/ Catalys Laser and Femtosecond Laser Assisted Cataract Surgery w/ LenSx Laser in Nuclear Sclerosis of the Lens, Posterior Subcapsular Cataract and Cortical Cataract, sponsored by Steven H. Linn, OD. Completed at 1 site in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2025-03-11.

Sponsored by Steven H. Linn, OD · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
22 Years and older
Sex
All
01

Study summary

This study compares two FDA approved Cataract Lasers.

Read the 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

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Conditions studied

  • Nuclear Sclerosis of the Lens
  • Posterior Subcapsular Cataract
  • Cortical Cataract

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03

In context

Cataract

1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.

This study's enrollment of 45 is below the median of 80 across 1,155 interventional studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

This is the only study on the registry with Steven H. Linn, OD as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
45 participants (actual)

Study arms

  • Active comparator
    Catalys Treated Eyes

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

    Procedure: Femtosecond Laser Assisted Cataract Surgery w/ Catalys Laser

  • Active comparator
    LenSx Treated Eyes

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

    Procedure: Femtosecond Laser Assisted Cataract Surgery w/ LenSx Laser

Interventions

  • ProcedureFemtosecond Laser Assisted Cataract Surgery w/ Catalys Laser

    Cohort subjects will undergo Femtosecond Laser Assisted Cataract Surgery in both eyes, with the Optimedica Catalys laser on one eye, and the Alcon LensX laser on the other. First eyes will be randomized.

    Also known as: Optimedica Catalys Precision Laser System

  • ProcedureFemtosecond Laser Assisted Cataract Surgery w/ LenSx Laser

    Cohort subjects will undergo Femtosecond Laser Assisted Cataract Surgery in both eyes, with the Optimedica Catalys laser on one eye, and the Alcon LensX laser on the other. First eyes will be randomized.

    Also known as: Alcon LenSx Laser System

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What researchers measure

Primary outcomes

  1. Cumulative Dissipated Energy

    The total amount of phacoemulsification energy delivered during the procedure.

    Time frame: Intraoperative

Secondary outcomes

  1. Complete Laser Capsulotomy

    Did the laser perform a complete capsulotomy with no tags or untreated segments.

    Time frame: Intraoperative

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Study locations

1 site
  • Hoopes Vision
    Salt Lake City, Utah 84020, United States
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References and documents

Publications

  • Cullen KA, Hall MJ, Golosinskiy A. Ambulatory surgery in the United States, 2006. Natl Health Stat Report. 2009 Jan 28;(11):1-25. PubMed 19294964 ↗
  • Vasavada AR, Vasavada V, Vasavada VA, Praveen MR, Johar SR, Gajjar D, Arora AI. Comparison of the effect of torsional and microburst longitudinal ultrasound on clear corneal incisions during phacoemulsification. J Cataract Refract Surg. 2012 May;38(5):833-9. doi: 10.1016/j.jcrs.2011.11.050. PubMed 22520307 ↗
  • Georgescu D, Kuo AF, Kinard KI, Olson RJ. A fluidics comparison of Alcon Infiniti, Bausch & Lomb Stellaris, and Advanced Medical Optics Signature phacoemulsification machines. Am J Ophthalmol. 2008 Jun;145(6):1014-1017. doi: 10.1016/j.ajo.2008.01.024. Epub 2008 Mar 17. PubMed 18343350 ↗
  • Dooley IJ, O'Brien PD. Subjective difficulty of each stage of phacoemulsification cataract surgery performed by basic surgical trainees. J Cataract Refract Surg. 2006 Apr;32(4):604-8. doi: 10.1016/j.jcrs.2006.01.045. PubMed 16698480 ↗
  • Gimbel HV, Neuhann T. Development, advantages, and methods of the continuous circular capsulorhexis technique. J Cataract Refract Surg. 1990 Jan;16(1):31-7. doi: 10.1016/s0886-3350(13)80870-x. PubMed 2299571 ↗
  • Friedman NJ, Palanker DV, Schuele G, Andersen D, Marcellino G, Seibel BS, Batlle J, Feliz R, Talamo JH, Blumenkranz MS, Culbertson WW. Femtosecond laser capsulotomy. J Cataract Refract Surg. 2011 Jul;37(7):1189-98. doi: 10.1016/j.jcrs.2011.04.022. PubMed 21700099 ↗
  • Artzen D, Lundstrom M, Behndig A, Stenevi U, Lydahl E, Montan P. Capsule complication during cataract surgery: Case-control study of preoperative and intraoperative risk factors: Swedish Capsule Rupture Study Group report 2. J Cataract Refract Surg. 2009 Oct;35(10):1688-93. doi: 10.1016/j.jcrs.2009.05.026. PubMed 19781460 ↗
  • Bellini LP, Brum GS, Grossi RS, Borowsky C. Cataract surgery complication rates. Ophthalmology. 2008 Aug;115(8):1432; author reply 1432-3. doi: 10.1016/j.ophtha.2008.04.009. No abstract available. PubMed 18675698 ↗
  • Richard J, Hoffart L, Chavane F, Ridings B, Conrath J. Corneal endothelial cell loss after cataract extraction by using ultrasound phacoemulsification versus a fluid-based system. Cornea. 2008 Jan;27(1):17-21. doi: 10.1097/ICO.0b013e3181583115. PubMed 18245961 ↗
  • Hayashi K, Hayashi H, Nakao F, Hayashi F. Risk factors for corneal endothelial injury during phacoemulsification. J Cataract Refract Surg. 1996 Oct;22(8):1079-84. doi: 10.1016/s0886-3350(96)80121-0. PubMed 8915805 ↗
  • Uy HS, Edwards K, Curtis N. Femtosecond phacoemulsification: the business and the medicine. Curr Opin Ophthalmol. 2012 Jan;23(1):33-9. doi: 10.1097/ICU.0b013e32834cd622. PubMed 22081031 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01878838
Lead sponsor
Steven H. Linn, OD
Responsible party
Steven H. Linn, OD (Study Coordinator, Hoopes Vision) — Sponsor-investigator
First posted
Jun 17, 2013
Start date
Apr 2013
Primary completion
Dec 2013
Completion
Jan 2014
Last update
Mar 11, 2025

Study contacts

Robert P Rivera, MD
principal investigator · Hoopes Vision
Steven H Linn, OD
study director · Hoopes Vision

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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