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This study compares two FDA approved Cataract Lasers.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Catalys Treated Eyes | Active Comparator | Patient's aged 22 and older with visually significant cataracts undergoing 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Femtosecond Laser Assisted Cataract Surgery w/ Catalys Laser | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Dissipated Energy | The total amount of phacoemulsification energy delivered during the procedure. | Intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Laser Capsulotomy | Did the laser perform a complete capsulotomy with no tags or untreated segments. | Intraoperative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert P Rivera, MD | Hoopes Vision | Principal Investigator |
| Steven H Linn, OD | Hoopes Vision | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hoopes Vision | Salt Lake City | Utah | 84020 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19294964 | Background | Cullen KA, Hall MJ, Golosinskiy A. Ambulatory surgery in the United States, 2006. Natl Health Stat Report. 2009 Jan 28;(11):1-25. | |
| 22520307 | Background | 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. |
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|
| Femtosecond Laser Assisted Cataract Surgery w/ LenSx Laser | Procedure | 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. |
|
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| 18343350 | Background | 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. |
| 16698480 | Background | 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. |
| 2299571 | Background | 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. |
| 21700099 | Background | 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. |
| 19781460 | Background | 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. |
| 18675698 | Background | 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. |
| 18245961 | Background | 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. |
| 8915805 | Background | 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. |
| 22081031 | Background | 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. |
| ID | Term |
|---|---|
| C563333 | Cataract, Age-Related Nuclear |
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