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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02890303
• Other study ID #: MYN-002
• Status: Completed
• Phase: N/A
• First received: August 31, 2016
• Last updated: April 24, 2018
• Start date: September 12, 2016
• Est. completion date: March 14, 2017

Study information

• Verified date: April 2018
• Source: Mynosys Cellular Devices, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

This study will evaluate outcome in subjects who have elected to have Zepto capsulotomies during cataract surgery with phacoemulsification to evaluate safety and effectiveness. The primary effectiveness endpoint is a complete capsulotomy in at least 95 percent of the cases. The primary safety endpoint is posterior capsular rupture and virtuous loss in 4 percent or less of the subjects. Other parameters to be captured during the study include anterior capsule tears, corneal touch, capsulotomy diameter, contraption of the Zepto capsulotomy, size of the corneal incision pre and post Zepto, interocular lens contraption and evaluation of zonular stability and the incidence and severity of adverse events. The criteria for patient success will be accessed based on the successful completion of a 360 degree capsulotomy without tissue bridges and no posterior capsule rupture and vitreous loss. The criteria for study success will be accessed based on a greater than or equal to 95 percent of the cases having a complete 360 degree capsulotomy without tissue bridges and less than 4 percent of subjects with posterior capsule rupture and vitreous loss.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 14, 2017
• Est. primary completion date: December 15, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

Inclusion Criteria:

1. Subjects must be age 22 or older,

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:

1. Disease or pathology in the treatment eye that will compromise visual performance or refractive outcome (e.g. previous refractive surgery),

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.

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• Zepto System
Anterior Capsulotomy using the Zepto System.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mynosys Cellular Devices, Inc.

References & Publications (23)

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. — View Citation

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. — View Citation

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. — View Citation

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):105-9. doi: 10.1016/j.jcrs.2012.08.065. — View Citation

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. — View Citation

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. — View Citation

Chang DF, Mamalis N, Werner L. Precision Pulse Capsulotomy: Preclinical Safety and Performance of a New Capsulotomy Technology. Ophthalmology. 2016 Feb;123(2):255-64. doi: 10.1016/j.ophtha.2015.10.008. Epub 2015 Nov 12. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Ionides A, Minassian D, Tuft S. Visual outcome following posterior capsule rupture during cataract surgery. Br J Ophthalmol. 2001 Feb;85(2):222-4. — View Citation

Lundström 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Nagy ZZ, Takacs AI, Filkorn T, Kránitz K, Gyenes A, Juhász É, Sándor GL, Kovacs I, Juhász 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. — View Citation

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. — View Citation

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. Epub 2006 Jul 24. — View Citation

Tan JH, Karwatowski WS. Phacoemulsification cataract surgery and unplanned anterior vitrectomy--is it bad news? Eye (Lond). 2002 Mar;16(2):117-20. — View Citation

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):265-74. doi: 10.1016/j.ophtha.2015.10.019. Epub 2015 Dec 23. — View Citation

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. — View Citation

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. Epub 2006 Oct 18. — View Citation

* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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