N/A
N=100
A Prospective Multi-Center Study of Anterior Lens Capsulotomy Using the Mynosys Zepto System
Cataract
Bottom Line
View on ClinicalTrials.gov: NCT02890303 ↗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
| Outcome | Result | p-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.
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.