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This study will evaluate outcome in subjects who have elected to have Zepto capsulotomies during cataract surgery with phacoemulsification.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zepto System | Device | Anterior Capsulotomy using the Zepto System. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26578447 | Background | 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. | |
| 25461300 | 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. |
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This study enrolled patients at 8 clinical study sites, with symptomatic age-related lens cataract desiring lens extraction and IOL implantation. The last patient was enrolled in the study in December 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Number | participants | During surgery |
|
Adverse event data will be collected from Day 0 (once the Informed Consent Form has been signed) until 1 month post surgery. Data points include Day 0, Day 1, 1 week and 1 month post-op.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Epithelial Erosion | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniel Marinsik | Mynosys Cellular Devices, Inc. | (510) 857-6296 | dmarinsik@mynosys.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 6, 2016 | Aug 16, 2017 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 8, 2016 | Aug 18, 2017 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| 19384016 | 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. |
| 16698484 | 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. |
| 12663021 | 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. |
| 10574810 | 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. |
| 21035868 | 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. |
| 15975469 | 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. |
| 11159491 | 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. |
| 11524187 | 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. |
| 10845015 | 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. |
| 17050577 | 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. |
| 16907135 | 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. |
| 26707416 | 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. |
| 23245363 | 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. |
| 20000286 | 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. |
| 16857511 | 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. |
| 15030840 | 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. |
| 18401555 | 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. |
| 11988808 | 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. |
| 24269139 | 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. |
| 24355719 | 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. |
| 23218822 | 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. |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Intraocular Pressure | Mean | Full Range | mm Hg |
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| Manifest Refraction | Count of Participants | Participants |
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| Uncorrected distance visual acuity (UCVA) | Mean | Full Range | ft |
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| Best spectacle corrected distance visual acuity (BSCVA) | Mean | Full Range | ft |
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| Slit Lamp | Number | percentage of participants |
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| Fundus Examination | Number | percentage of participants |
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| Dilated Pupil Size | Mean | Full Range | mm |
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| Units | Counts |
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| Participants |
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| 0 |
| 100 |
| 0 |
| 100 |
| 5 |
| 100 |
| Macular Edema | Eye disorders | Systematic Assessment |
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| Anterior Capsule Tear | Eye disorders | Systematic Assessment |
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| Posterior Tear without Vitreous Loss | Eye disorders | Systematic Assessment |
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| Headache | General disorders | Systematic Assessment |
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| Elevated IOP | Eye disorders | Systematic Assessment |
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| Ache in Treatment Eye | Eye disorders | Systematic Assessment |
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