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

Mynosys Cellular Devices

Status: Completed

Conditions: Cataract

Treatments: Device: Zepto System

Study type: Interventional

Funder types: Industry

Identifiers

NCT02890303

MYN-002

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Zepto Capsulotomy

Experimental group

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)

Treatment:

Device: Zepto System