Clinical Investigation of the Next Generation Phaco System (VERITAS Vision System)

Johnson & Johnson Surgical Vision, Inc.2 sites in 2 countries79 target enrollmentSeptember 28, 2020

ConditionsCataract

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cataract
Sponsor: Johnson & Johnson Surgical Vision, Inc.
Enrollment: 79
Locations: 2
Primary Endpoint: Proportion of Eyes With Surgeon Satisfaction Rating Score of 4 or 5
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study is a prospective, open-label clinical study of the VERITAS Vision System.

The study will be conducted at up to three sites, with minimum 55 eyes and up to 150 eyes to be treated. The investigator or designee will perform the cataract surgery with the VERITAS Vision System on the subjects. The data from the system log files, the questionnaire, the operative report and other medical records will be used to assess the clinical utilization of the VERITAS Vision System.

Registry

clinicaltrials.gov

Start Date

September 28, 2020

End Date

May 1, 2021

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Johnson & Johnson Surgical Vision, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Minimum 22 years of age.
•Cataracts for which cataract extraction and posterior chamber IOL implantation have been planned.
•Availability, willingness, ability and sufficient cognitive awareness to comply with study requirements, examination procedures, and visits.
•Be willing to provide informed consent and authorization to disclose protected health information or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical procedures in the governing countries.

Exclusion Criteria

•Expected surgical difficulties at the time of cataract extraction, which may increase the potential for complications (e.g., persistent bleeding, significant iris damage, uncontrolled intraocular pressure change, or significant vitreous prolapse or loss).
•Subjects with only one good eye (e.g. amblyopic condition etc.).
•Subjects with conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration, including pseudoexfoliation, trauma, or posterior capsule defects.
•History or current use of alpha-1 antagonist medication (e.g., Flomax).
•Any condition which, in the Investigator's opinion, would make it unsafe (for the subject or for the study personnel) to treat the subject as part of this research study or for which cataract surgery is contraindicated.
•Pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils).
•Is pregnant, or is breast feeding, or intend to become pregnant during the study.
•Concurrent participation or expected participation in an interventional (i.e., surgical or pharmaceutical interventional) clinical trial within 14 days prior to study screening.

Outcomes

Primary Outcomes

Proportion of Eyes With Surgeon Satisfaction Rating Score of 4 or 5

Time Frame: 1 day postoperative

Surgeons rated the following Questionnaire items regarding satisfaction with the VERITAS Vision System, using 1 - 5 scale (acceptability considered favorable for scores of 4 and 5, where 4 is Satisfied and 5 is Very Satisfied)