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

April 24, 2018 updated by: Mynosys Cellular Devices, Inc.
This study will evaluate outcome in subjects who have elected to have Zepto capsulotomies during cataract surgery with phacoemulsification.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Zepto Capsulotomy
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
Anterior Capsulotomy using the Zepto System.
Other Names:
  • Zepto

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete Capsulotomy
Time Frame: During surgery

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mynosys Cellular Devices, Inc.

Investigators

  • Principal Investigator: William Christie, M.D., Scott & Christie and Associates P C
  • Principal Investigator: Daniel H Chang, M.D., Empire Eye and Laser Center
  • Principal Investigator: David F Chang, M.D., Peninsula Eye Surgery Center
  • Principal Investigator: Eric D Donnenfeld, M.D., Lasik Garden City
  • Principal Investigator: Philip C Hoopes, M.D., Hoopes Vision
  • Principal Investigator: John Vukich, M.D., Davis Duehr Dean Clinic
  • Principal Investigator: Farrell C Tyson II, M.D., Cape Coral Eye Ctr Pa
  • Principal Investigator: Vance Thompson, M.D, Vance Thompson Vision

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 12, 2016

Primary Completion (Actual)

December 15, 2016

Study Completion (Actual)

March 14, 2017

Study Registration Dates

First Submitted

August 31, 2016

First Submitted That Met QC Criteria

August 31, 2016

First Posted (Estimate)

September 7, 2016

Study Record Updates

Last Update Posted (Actual)

April 27, 2018

Last Update Submitted That Met QC Criteria

April 24, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MYN-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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