A Prospective Multi-Center Study of Anterior Lens Capsulotomy Using the Mynosys Zepto System

NCT02890303 | Completed Results FDA Device

• 1 other identifier: MYN-002
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will evaluate outcome in subjects who have elected to have Zepto capsulotomies during cataract surgery with phacoemulsification.

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

• Complete Capsulotomy

  A successful complete Zepto capsulotomy is defined in this protocol to be one that results in a complete 360 degree capsulotomy without any residual tissue bridges visible to the surgeon. If there are such tissue bridges, the surgeon completes the capsulotomy manually. The primary effectiveness endpoint was defined as :Complete capsulotomy (target ≥ 95% of cases).

  During surgery

Study Arms (1)

Zepto Capsulotomy

EXPERIMENTAL

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)

Device: Zepto System

Interventions

Zepto System DEVICE

Anterior Capsulotomy using the Zepto System.

Also known as: Zepto

Zepto Capsulotomy

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must be age 22 or older,
• 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,
• Subjects must be willing and able to return for scheduled treatment and follow-up examinations for 3 months.

You may not qualify if:

• Disease or pathology in the treatment eye that will compromise visual performance or refractive outcome (e.g. previous refractive surgery),
• Zonular abnormality,
• Posterior polar cataract,
• Fellow eye with acuity less than 20/200,
• Any prior ocular surgery of the study eye,
• Pupillary dilation during the pre-operative exam of less than 7 mm in diameter,
• Proliferative diabetic retinopathy,
• Disorders of the ocular muscles, such as nystagmus or strabismus,
• Chronic uveitis,
• Abnormal corneal endothelium,
• Subjects on medications with, in the opinion of the surgeon, significant ocular side effects,
• Pregnant or nursing (lactating) women,
• Implanted ocular device or drug in the study eye,
• 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),
• Current participation in another drug or device clinical study, or participation in such a clinical study within the six months.

Sponsors & Collaborators

• Mynosys Cellular Devices, Inc.: lead

Related Publications (23)

• 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.

  PMID: 26578447 BACKGROUND

• 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.

  PMID: 25461300 BACKGROUND

• 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.

  PMID: 19384016 BACKGROUND

• 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.

  PMID: 16698484 BACKGROUND

• 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.

  PMID: 12663021 BACKGROUND

• 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.

  PMID: 10574810 BACKGROUND

• 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.

  PMID: 21035868 BACKGROUND

• 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.

  PMID: 15975469 BACKGROUND

• 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.

  PMID: 11159491 BACKGROUND

• 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.

  PMID: 11524187 BACKGROUND

• 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.

  PMID: 10845015 BACKGROUND

• 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.

  PMID: 17050577 BACKGROUND

• 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.

  PMID: 16907135 BACKGROUND

• 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.

  PMID: 26707416 BACKGROUND

• 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.

  PMID: 23245363 BACKGROUND

• 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.

  PMID: 20000286 BACKGROUND

• 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.

  PMID: 16857511 BACKGROUND

• 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.

  PMID: 15030840 BACKGROUND

• 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.

  PMID: 18401555 BACKGROUND

• 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.

  PMID: 11988808 BACKGROUND

• 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.

  PMID: 24269139 BACKGROUND

• 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.

  PMID: 24355719 BACKGROUND

• 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.

  PMID: 23218822 BACKGROUND

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Results Point of Contact

• Title: Daniel Marinsik
• Organization: Mynosys Cellular Devices, Inc.

dmarinsik@mynosys.com

(510) 857-6296

Study Officials

• William Christie, M.D.

  Scott & Christie and Associates P C

  PRINCIPAL INVESTIGATOR

• Daniel H Chang, M.D.

  Empire Eye and Laser Center

  PRINCIPAL INVESTIGATOR

• David F Chang, M.D.

  Peninsula Eye Surgery Center

  PRINCIPAL INVESTIGATOR

• Eric D Donnenfeld, M.D.

  Lasik Garden City

  PRINCIPAL INVESTIGATOR

• Philip C Hoopes, M.D.

  Hoopes Vision

  PRINCIPAL INVESTIGATOR

• John Vukich, M.D.

  Davis Duehr Dean Clinic

  PRINCIPAL INVESTIGATOR

• Farrell C Tyson II, M.D.

  Cape Coral Eye Ctr Pa

  PRINCIPAL INVESTIGATOR

• Vance Thompson, M.D

  Vance Thompson Vision

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2016
• First Posted: September 7, 2016
• Study Start: September 12, 2016
• Primary Completion: December 15, 2016
• Study Completion: March 14, 2017
• Last Updated: April 27, 2018
• Results First Posted: April 27, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share