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

Cortical Cataract Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01878838
• Other study ID #: HV-AVO1
• Status: Completed
• Phase: N/A
• First received: June 12, 2013
• Last updated: August 18, 2015
• Start date: April 2013
• Est. completion date: January 2014

Study information

• Verified date: August 2015
• Source: Hoopes Vision
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study compares two FDA approved Cataract Lasers.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: January 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 22 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Femtosecond 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.
• Femtosecond 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.

Locations

Country	Name	City	State
United States	Hoopes Vision	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Steve H. Linn, OD

Country where clinical trial is conducted

United States, 

References & Publications (11)

Artzén D, Lundström 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. — View 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. — View Citation

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

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative Dissipated Energy	The total amount of phacoemulsification energy delivered during the procedure.	Intraoperative	No
Secondary	Complete Laser Capsulotomy	Did the laser perform a complete capsulotomy with no tags or untreated segments.	Intraoperative	No