Back to results

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

Primary Purpose

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

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Femtosecond Laser Assisted Cataract Surgery w/ Catalys Laser

Femtosecond Laser Assisted Cataract Surgery w/ LenSx Laser

About this trial

This is an interventional treatment trial for Nuclear Sclerosis of the Lens

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Hoopes Vision

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Catalys Treated Eyes

LenSx Treated Eyes

Arm Description

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

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

Outcomes

Primary Outcome Measures

Cumulative Dissipated Energy

The total amount of phacoemulsification energy delivered during the procedure.

Secondary Outcome Measures

Complete Laser Capsulotomy

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

Full Information

NCT ID

NCT01878838

First Posted

June 12, 2013

Last Updated

August 18, 2015

Sponsor

Steve H. Linn, OD

1. Study Identification

Unique Protocol Identification Number

NCT01878838

Brief Title

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

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Completed

Study Start Date

April 2013 (undefined)

Primary Completion Date

December 2013 (Actual)

Study Completion Date

January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Steve H. Linn, OD

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Randomized

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Catalys Treated Eyes

Arm Type

Active Comparator

Arm Description

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

Arm Title

LenSx Treated Eyes

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Femtosecond Laser Assisted Cataract Surgery w/ Catalys Laser

Other Intervention Name(s)

Optimedica Catalys Precision Laser System

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Femtosecond Laser Assisted Cataract Surgery w/ LenSx Laser

Other Intervention Name(s)

Alcon LenSx Laser System

Intervention Description

Primary Outcome Measure Information:

Title

Cumulative Dissipated Energy

Description

The total amount of phacoemulsification energy delivered during the procedure.

Time Frame

Intraoperative

Secondary Outcome Measure Information:

Title

Complete Laser Capsulotomy

Description

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

Time Frame

Intraoperative

10. Eligibility

Sex

All

Minimum Age & Unit of Time

22 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert P Rivera, MD

Organizational Affiliation

Hoopes Vision

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Steve H Linn, OD

Organizational Affiliation

Hoopes Vision

Official's Role

Study Director

Facility Information:

Facility Name

Hoopes Vision

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84020

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

19294964

Citation

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

Results Reference

background

PubMed Identifier

22520307

Citation

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.

Results Reference

background

PubMed Identifier

18343350

Citation

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.

Results Reference

background

PubMed Identifier

16698480

Citation

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.

Results Reference

background

PubMed Identifier

2299571

Citation

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.

Results Reference

background

PubMed Identifier

21700099

Citation

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. Erratum In: J Cataract Refract Surg. 2011 Sep;37(9):1742.

Results Reference

background

PubMed Identifier

19781460

Citation

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.

Results Reference

background

PubMed Identifier

18675698

Citation

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.

Results Reference

background

PubMed Identifier

18245961

Citation

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.

Results Reference

background

PubMed Identifier

8915805

Citation

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.

Results Reference

background

PubMed Identifier

22081031

Citation

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.

Results Reference

background

Learn more about this trial

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

We'll reach out to this number within 24 hrs