Clinical Evaluation of the Next Generation Phaco System

NCT ID: NCT04332640

Last Updated: 2022-06-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 79 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-28
• Study Completion Date: 2021-05-01

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.

Conditions

Cataract

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Next Generation Phaco System

VERITAS Vision System

Group Type: EXPERIMENTAL

VERITAS Vision System

Intervention Type: DEVICE

The investigators or designees will perform routine small-incision cataract surgery via phacoemulsification and use the VERITAS Vision system. The Investigator or designee will then complete a questionnaire regarding the clinical use of the VERITAS Vision system. The system log files automatically generated by the VERITAS Vision system after completion of each surgery will be collected.

Interventions

VERITAS Vision System

The investigators or designees will perform routine small-incision cataract surgery via phacoemulsification and use the VERITAS Vision system. The Investigator or designee will then complete a questionnaire regarding the clinical use of the VERITAS Vision system. The system log files automatically generated by the VERITAS Vision system after completion of each surgery will be collected.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johnson & Johnson Surgical Vision, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Johnson & Johnson Surgical Vision Clinical Trial

Role: STUDY_DIRECTOR

Johnson & Johnson Surgical Vision

Locations

ACE Eyecare, Inc

Bakersfield, California, United States

Grupo Oftalmo & Plastico, Centro de Oftalmologia y Cirugia Plastica

El Escalón, San Salvador Department, El Salvador

Countries

United States; El Salvador

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

ALPI-101-SYST

Identifier Type: -

Identifier Source: org_study_id