Back to resultsA Prospective Multi-Center Study of Anterior Lens Capsulotomy Using the Mynosys Zepto System
Primary Purpose
Cataract
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Zepto System
Sponsored by
About this trial
This is an interventional treatment trial for Cataract
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Zepto Capsulotomy
Arm Description
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)
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT02890303
First Posted
August 31, 2016
Last Updated
April 24, 2018
Sponsor
Mynosys Cellular Devices, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02890303
Brief Title
A Prospective Multi-Center Study of Anterior Lens Capsulotomy Using the Mynosys Zepto System
Official Title
A Prospective Multi-Center Study of Anterior Lens Capsulotomy Using the Mynosys Zepto System
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
September 12, 2016 (Actual)
Primary Completion Date
December 15, 2016 (Actual)
Study Completion Date
March 14, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mynosys Cellular Devices, Inc.
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will evaluate outcome in subjects who have elected to have Zepto capsulotomies during cataract surgery with phacoemulsification.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Zepto Capsulotomy
Arm Type
Experimental
Arm Description
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)
Intervention Type
Device
Intervention Name(s)
Zepto System
Other Intervention Name(s)
Zepto
Intervention Description
Anterior Capsulotomy using the Zepto System.
Primary Outcome Measure Information:
Title
Complete Capsulotomy
Description
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).
Time Frame
During surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Christie, M.D.
Organizational Affiliation
Scott & Christie and Associates P C
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Daniel H Chang, M.D.
Organizational Affiliation
Empire Eye and Laser Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David F Chang, M.D.
Organizational Affiliation
Peninsula Eye Surgery Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eric D Donnenfeld, M.D.
Organizational Affiliation
Lasik Garden City
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Philip C Hoopes, M.D.
Organizational Affiliation
Hoopes Vision
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John Vukich, M.D.
Organizational Affiliation
Davis Duehr Dean Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Farrell C Tyson II, M.D.
Organizational Affiliation
Cape Coral Eye Ctr Pa
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vance Thompson, M.D
Organizational Affiliation
Vance Thompson Vision
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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A Prospective Multi-Center Study of Anterior Lens Capsulotomy Using the Mynosys Zepto System
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