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

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

Detailed Description
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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.

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

Conditions
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Cataract

Intervention / Treatment
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* Device: Zepto System


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zepto Capsulotomy<br>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<br>* Anterior Capsulotomy using the Zepto System.<br>* Other names: Zepto;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |