A Prospective Multi-Center Study of Anterior Lens Capsulotomy Using the Mynosys Zepto System
NCT ID: NCT02890303
Last Updated: 2018-04-27
Study Results
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View full resultsBasic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2016-09-12
2017-03-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Zepto Capsulotomy
This study will evaluate outcome in subjects who have elected to have Zepto capsulotomies during cataract surgery. Effectiveness Rate - An effectiveness rate of 95% complete capsulotomies provides reasonable assurance that the Zepto system is effective. Primary Safety Endpoint - Posterior Capsular Rupture \& Vitreous Loss (4% or less)
Zepto System
Anterior Capsulotomy using the Zepto System.
Interventions
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Zepto System
Anterior Capsulotomy using the Zepto System.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subjects consenting to undergoing phacoemulsification and IOL implant surgery for the treatment of symptomatic age related lens cataract, and then electing to undergo ZeptoTM capsulotomy,
3. Subjects must be willing and able to return for scheduled treatment and follow-up examinations for 3 months.
Exclusion Criteria
2. Zonular abnormality,
3. Posterior polar cataract,
4. Fellow eye with acuity less than 20/200,
5. Any prior ocular surgery of the study eye,
6. Pupillary dilation during the pre-operative exam of less than 7 mm in diameter,
7. Proliferative diabetic retinopathy,
8. Disorders of the ocular muscles, such as nystagmus or strabismus,
9. Chronic uveitis,
10. Abnormal corneal endothelium,
11. Subjects on medications with, in the opinion of the surgeon, significant ocular side effects,
12. Pregnant or nursing (lactating) women,
13. Implanted ocular device or drug in the study eye,
14. Any other condition, which in the judgment of the investigator would prevent the subject from completing the study (e.g. documented diagnosis or treatment for symptoms associated with dementia, mental illness),
15. Current participation in another drug or device clinical study, or participation in such a clinical study within the six months.
22 Years
ALL
No
Sponsors
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Mynosys Cellular Devices, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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William Christie, M.D.
Role: PRINCIPAL_INVESTIGATOR
Scott & Christie and Associates P C
Daniel H Chang, M.D.
Role: PRINCIPAL_INVESTIGATOR
Empire Eye and Laser Center
David F Chang, M.D.
Role: PRINCIPAL_INVESTIGATOR
Peninsula Eye Surgery Center
Eric D Donnenfeld, M.D.
Role: PRINCIPAL_INVESTIGATOR
Lasik Garden City
Philip C Hoopes, M.D.
Role: PRINCIPAL_INVESTIGATOR
Hoopes Vision
John Vukich, M.D.
Role: PRINCIPAL_INVESTIGATOR
Davis Duehr Dean Clinic
Farrell C Tyson II, M.D.
Role: PRINCIPAL_INVESTIGATOR
Cape Coral Eye Ctr Pa
Vance Thompson, M.D
Role: PRINCIPAL_INVESTIGATOR
Vance Thompson Vision
References
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Chang DF, Mamalis N, Werner L. Precision Pulse Capsulotomy: Preclinical Safety and Performance of a New Capsulotomy Technology. Ophthalmology. 2016 Feb;123(2):255-264. doi: 10.1016/j.ophtha.2015.10.008. Epub 2015 Nov 12.
Carifi G, Miller MH, Pitsas C, Zygoura V, Deshmukh RR, Kopsachilis N, Maurino V. Complications and outcomes of phacoemulsification cataract surgery complicated by anterior capsule tear. Am J Ophthalmol. 2015 Mar;159(3):463-9. doi: 10.1016/j.ajo.2014.11.027. Epub 2014 Nov 26.
Agrawal V, Upadhyay J; Indian Cataract Risk Stratification Study group. Validation of scoring system for preoperative stratification of intra-operative risks of complications during cataract surgery: Indian multi-centric study. Indian J Ophthalmol. 2009 May-Jun;57(3):213-5. doi: 10.4103/0301-4738.49396.
Ang GS, Whyte IF. Effect and outcomes of posterior capsule rupture in a district general hospital setting. J Cataract Refract Surg. 2006 Apr;32(4):623-7. doi: 10.1016/j.jcrs.2006.01.047.
Chan FM, Mathur R, Ku JJ, Chen C, Chan SP, Yong VS, Au Eong KG. Short-term outcomes in eyes with posterior capsule rupture during cataract surgery. J Cataract Refract Surg. 2003 Mar;29(3):537-41. doi: 10.1016/s0886-3350(02)01622-x.
Desai P, Minassian DC, Reidy A. National cataract surgery survey 1997-8: a report of the results of the clinical outcomes. Br J Ophthalmol. 1999 Dec;83(12):1336-40. doi: 10.1136/bjo.83.12.1336.
Greenberg PB, Tseng VL, Wu WC, Liu J, Jiang L, Chen CK, Scott IU, Friedmann PD. Prevalence and predictors of ocular complications associated with cataract surgery in United States veterans. Ophthalmology. 2011 Mar;118(3):507-14. doi: 10.1016/j.ophtha.2010.07.023. Epub 2010 Oct 29.
Hyams M, Mathalone N, Herskovitz M, Hod Y, Israeli D, Geyer O. Intraoperative complications of phacoemulsification in eyes with and without pseudoexfoliation. J Cataract Refract Surg. 2005 May;31(5):1002-5. doi: 10.1016/j.jcrs.2004.09.051.
Ionides A, Minassian D, Tuft S. Visual outcome following posterior capsule rupture during cataract surgery. Br J Ophthalmol. 2001 Feb;85(2):222-4. doi: 10.1136/bjo.85.2.222.
Lundstrom M, Barry P, Leite E, Seward H, Stenevi U. 1998 European Cataract Outcome Study: report from the European Cataract Outcome Study Group. J Cataract Refract Surg. 2001 Aug;27(8):1176-84. doi: 10.1016/s0886-3350(01)00772-6.
Martin KR, Burton RL. The phacoemulsification learning curve: per-operative complications in the first 3000 cases of an experienced surgeon. Eye (Lond). 2000 Apr;14 ( Pt 2):190-5. doi: 10.1038/eye.2000.52.
Zaidi FH, Corbett MC, Burton BJ, Bloom PA. Raising the benchmark for the 21st century--the 1000 cataract operations audit and survey: outcomes, consultant-supervised training and sourcing NHS choice. Br J Ophthalmol. 2007 Jun;91(6):731-6. doi: 10.1136/bjo.2006.104216. Epub 2006 Oct 18.
Simanovskii DM, Mackanos MA, Irani AR, O'Connell-Rodwell CE, Contag CH, Schwettman HA, Palanker DV. Cellular tolerance to pulsed hyperthermia. Phys Rev E Stat Nonlin Soft Matter Phys. 2006 Jul;74(1 Pt 1):011915. doi: 10.1103/PhysRevE.74.011915. Epub 2006 Jul 24.
Thompson VM, Berdahl JP, Solano JM, Chang DF. Comparison of Manual, Femtosecond Laser, and Precision Pulse Capsulotomy Edge Tear Strength in Paired Human Cadaver Eyes. Ophthalmology. 2016 Feb;123(2):265-274. doi: 10.1016/j.ophtha.2015.10.019. Epub 2015 Dec 23.
Auffarth GU, Reddy KP, Ritter R, Holzer MP, Rabsilber TM. Comparison of the maximum applicable stretch force after femtosecond laser-assisted and manual anterior capsulotomy. J Cataract Refract Surg. 2013 Jan;39(1):105-109. doi: 10.1016/j.jcrs.2012.08.065.
Nagy Z, Takacs A, Filkorn T, Sarayba M. Initial clinical evaluation of an intraocular femtosecond laser in cataract surgery. J Refract Surg. 2009 Dec;25(12):1053-60. doi: 10.3928/1081597X-20091117-04.
Trivedi RH, Wilson ME Jr, Bartholomew LR. Extensibility and scanning electron microscopy evaluation of 5 pediatric anterior capsulotomy techniques in a porcine model. J Cataract Refract Surg. 2006 Jul;32(7):1206-13. doi: 10.1016/j.jcrs.2005.12.144.
Androudi S, Brazitikos PD, Papadopoulos NT, Dereklis D, Symeon L, Stangos N. Posterior capsule rupture and vitreous loss during phacoemulsification with or without the use of an anterior chamber maintainer. J Cataract Refract Surg. 2004 Feb;30(2):449-52. doi: 10.1016/S0886-3350(03)00584-4.
Mearza AA, Ramanathan S, Bidgood P, Horgan S. Visual outcome in cataract surgery complicated by vitreous loss in a district general hospital. Int Ophthalmol. 2009 Jun;29(3):157-60. doi: 10.1007/s10792-008-9214-6. Epub 2008 Apr 10.
Tan JH, Karwatowski WS. Phacoemulsification cataract surgery and unplanned anterior vitrectomy--is it bad news? Eye (Lond). 2002 Mar;16(2):117-20. doi: 10.1038/sj.eye.6700015.
Chang JS, Chen IN, Chan WM, Ng JC, Chan VK, Law AK. Initial evaluation of a femtosecond laser system in cataract surgery. J Cataract Refract Surg. 2014 Jan;40(1):29-36. doi: 10.1016/j.jcrs.2013.08.045. Epub 2013 Nov 22.
Nagy ZZ, Takacs AI, Filkorn T, Kranitz K, Gyenes A, Juhasz E, Sandor GL, Kovacs I, Juhasz T, Slade S. Complications of femtosecond laser-assisted cataract surgery. J Cataract Refract Surg. 2014 Jan;40(1):20-8. doi: 10.1016/j.jcrs.2013.08.046.
Roberts TV, Lawless M, Bali SJ, Hodge C, Sutton G. Surgical outcomes and safety of femtosecond laser cataract surgery: a prospective study of 1500 consecutive cases. Ophthalmology. 2013 Feb;120(2):227-33. doi: 10.1016/j.ophtha.2012.10.026. Epub 2012 Dec 6.
Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
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MYN-002
Identifier Type: -
Identifier Source: org_study_id
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