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N/A N=100 Treatment

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

Cataract

Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Apr 2018
Primary outcome: Primary: Complete Capsulotomy — 98 participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Zepto System (Device)
Age
Adult, Older Adult · 22+ yrs
Sex
All
Sponsor
Mynosys Cellular Devices, Inc.
Primary completion
Dec 2016

Outcome Measures

OutcomeResultp-value
PRIMARY
Complete Capsulotomy
98

Summary

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

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02890303). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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