NCT01878838

Brief Summary

This study compares two FDA approved Cataract Lasers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 12, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 17, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

March 11, 2025

Status Verified

March 1, 2025

Enrollment Period

8 months

First QC Date

June 12, 2013

Last Update Submit

March 10, 2025

Conditions

Nuclear Sclerosis of the LensPosterior Subcapsular CataractCortical Cataract

Outcome Measures

Primary Outcomes (1)

  • Cumulative Dissipated Energy

    The total amount of phacoemulsification energy delivered during the procedure.

    Intraoperative

Secondary Outcomes (1)

  • Complete Laser Capsulotomy

    Intraoperative

Study Arms (2)

Catalys Treated Eyes

ACTIVE COMPARATOR

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

LenSx Treated Eyes

ACTIVE COMPARATOR

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

Femtosecond Laser Assisted Cataract Surgery w/ Catalys LaserPROCEDURE

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
Catalys Treated Eyes
Femtosecond Laser Assisted Cataract Surgery w/ LenSx LaserPROCEDURE

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
LenSx Treated Eyes

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hoopes Vision

Salt Lake City, Utah, 84020, United States

Location

Related Publications (11)

  • Cullen KA, Hall MJ, Golosinskiy A. Ambulatory surgery in the United States, 2006. Natl Health Stat Report. 2009 Jan 28;(11):1-25.

    PMID: 19294964BACKGROUND

  • 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.

    PMID: 22520307BACKGROUND

  • 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.

    PMID: 18343350BACKGROUND

  • 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.

    PMID: 16698480BACKGROUND

  • 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.

    PMID: 2299571BACKGROUND

  • 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.

    PMID: 21700099BACKGROUND

  • 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.

    PMID: 19781460BACKGROUND

  • 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.

    PMID: 18675698BACKGROUND

  • 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.

    PMID: 18245961BACKGROUND

  • 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.

    PMID: 8915805BACKGROUND

  • 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.

    PMID: 22081031BACKGROUND

MeSH Terms

Conditions

Cataract, Age-Related Nuclear

Study Officials

  • Robert P Rivera, MD

    Hoopes Vision

    PRINCIPAL INVESTIGATOR

  • Steven H Linn, OD

    Hoopes Vision

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Study Coordinator

Study Record Dates

First Submitted

June 12, 2013

First Posted

June 17, 2013

Study Start

April 1, 2013

Primary Completion

December 1, 2013

Study Completion

January 1, 2014

Last Updated

March 11, 2025

Record last verified: 2025-03

Locations

US(1)