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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02890303
Recruitment Status : Completed
First Posted : September 7, 2016
Results First Posted : April 27, 2018
Last Update Posted : April 27, 2018
Sponsor:
Information provided by (Responsible Party):
Mynosys Cellular Devices, Inc.

Study Description
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Brief Summary:
This study will evaluate outcome in subjects who have elected to have Zepto capsulotomies during cataract surgery with phacoemulsification.

Condition or disease Intervention/treatment Phase
Cataract Device: Zepto System Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Multi-Center Study of Anterior Lens Capsulotomy Using the Mynosys Zepto System
Actual Study Start Date : September 12, 2016
Actual Primary Completion Date : December 15, 2016
Actual Study Completion Date : March 14, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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)
 Device: Zepto System
Anterior Capsulotomy using the Zepto System.
Other Name: Zepto


Outcome Measures
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Primary Outcome Measures :
  1. 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).



Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02890303


Sponsors and Collaborators
Mynosys Cellular Devices, Inc.
Investigators
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Principal Investigator: 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
  Study Documents (Full-Text)

Documents provided by Mynosys Cellular Devices, Inc.:
Study Protocol  [PDF] July 6, 2016
Informed Consent Form  [PDF] September 8, 2016

More Information
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Publications:

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Responsible Party: Mynosys Cellular Devices, Inc.
ClinicalTrials.gov Identifier: NCT02890303    
Other Study ID Numbers: MYN-002
First Posted: September 7, 2016    Key Record Dates
Results First Posted: April 27, 2018
Last Update Posted: April 27, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases