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

A study testing Zepto System in people with Cataract, run by Mynosys Cellular Devices, Inc..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Ages 22 years and older
Conditions the study is for: Cataract
What is being tested?: Zepto System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: No sites listed yet
Study dates: 12 Sep 2016to 14 Mar 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 22 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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,

Show all 15Show fewer

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.

About this study

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

Read the detailed 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.

Conditions: Cataract
Being tested: Zepto System
Medical subject headings: Cataract

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Zepto SystemDevice
Also called Zepto
Anterior Capsulotomy using the Zepto System.

Study groups in NCT02890303
Study group	Role	What they receive
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) Receives: Device: Zepto System

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: During surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Sep 201614 Mar 2017

First posted7 Sep 2016 (estimated)
Study start12 Sep 2016
Primary completion15 Dec 2016
Study completion14 Mar 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (23)Papers the sponsor has linked to this study.
Other trials for CataractStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02890303
Sponsor's protocol ID: MYN-002
Status last verified: Apr 2018
First submitted: 31 Aug 2016
Last updated: 27 Apr 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

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.
PubMed 26578447
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.
PubMed 25461300
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.
PubMed 19384016
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.
PubMed 16698484
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.
PubMed 12663021
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.
PubMed 10574810
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.
PubMed 21035868
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.
PubMed 15975469
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.
PubMed 11159491
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.
PubMed 11524187
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.
PubMed 10845015
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.
PubMed 17050577
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.
PubMed 16907135
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.
PubMed 26707416
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.
PubMed 23245363

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 27 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective Multi-Center Study of Anterior Lens Capsulotomy Using the Mynosys Zepto System
ClinicalTrials.gov ID: NCT02890303
Acronym / sponsor ID: MYN-002
Conditions: Cataract
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Mynosys Cellular Devices, Inc.Industry (pharma, biotech, devices)
Study start: 12 Sep 2016 (actual)
Primary completion: 15 Dec 2016 (actual)
Study completion: 14 Mar 2017 (actual)
First posted: 7 Sep 2016 (estimated)
Results: Posted 27 Apr 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Zepto Capsulotomy	Experimental	Device: Zepto SystemThis 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)

Who may qualify

Ages: 22 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (15 listed)

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,

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Zepto SystemAlso: ZeptoAnterior Capsulotomy using the Zepto System.	Device	Zepto Capsulotomy

Primary outcome

Complete Capsulotomy
Time frame: During surgery
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).

Results and safety

Results posted to the registry on 27 Apr 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Zepto Capsulotomy	100	100

Primary outcome: Complete Capsulotomy

Time frame: During surgery. Number. Unit: participants

Measure	Zepto Capsulotomy n = 100
Value	98

Adverse events

Time frame: 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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Zepto Capsulotomy	0 of 100 (0%)	5 of 100 (5%)	0 of 100

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 26578447Chang 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.
Background: PubMed 25461300Carifi 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.
Background: PubMed 19384016Agrawal 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.
Background: PubMed 16698484Ang 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.
Background: PubMed 12663021Chan 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.
Background: PubMed 10574810Desai 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.
Background: PubMed 21035868Greenberg 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.
Background: PubMed 15975469Hyams 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.
Background: PubMed 11159491Ionides 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.
Background: PubMed 11524187Lundstrom 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.
Background: PubMed 10845015Martin 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.
Background: PubMed 17050577Zaidi 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

William Christie, M.D. principal investigator

Scott & Christie and Associates P C

Daniel H Chang, M.D. principal investigator

Empire Eye and Laser Center

David F Chang, M.D. principal investigator

Peninsula Eye Surgery Center

Questions about this trial

What is this clinical trial studying?

A study testing Zepto System in people with Cataract, run by Mynosys Cellular Devices, Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete Capsulotomy (time frame: During surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02890303, which also lists 23 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2018.