Clinical Evaluation of the Next Generation Phaco System

NCT04332640 | Completed Results FDA Device

• 1 other identifier: ALPI-101-SYST
• Study Type: interventional
• Target: 79
• Locations: 2 countries
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

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

  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)

  1 day postoperative

Study Arms (1)

Next Generation Phaco System

EXPERIMENTAL

VERITAS Vision System

Device: VERITAS Vision System

Interventions

VERITAS Vision System 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.

Next Generation Phaco System

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johnson & Johnson Surgical Vision, Inc.: lead

Study Sites (2)

ACE Eyecare, Inc

Bakersfield, California, 93301, United States

Location

Grupo Oftalmo & Plastico, Centro de Oftalmologia y Cirugia Plastica

El Escalón, San Salvador Department, El Salvador

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Results Point of Contact

• Title: Head of Clinical Science
• Organization: Johnson & Johnson Surgical Vision

LVarga17@ITS.JNJ.com

7142478200

Study Officials

• Johnson & Johnson Surgical Vision Clinical Trial

  Johnson & Johnson Surgical Vision

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2020
• First Posted: April 2, 2020
• Study Start: September 28, 2020
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: June 15, 2022
• Results First Posted: June 1, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share

Locations

EL (1); US (1)