Clinical Evaluation of the Next Generation Phaco System

Cataract Clinical Trial

— ALPINE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04332640
• Other study ID #: ALPI-101-SYST
• Status: Completed
• Phase: N/A
• Start date: September 28, 2020
• Est. completion date: May 1, 2021

Study information

• Verified date: June 2022
• Source: Johnson & Johnson Surgical Vision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: May 1, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• 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.

Locations

Country	Name	City	State
El Salvador	Grupo Oftalmo & Plastico, Centro de Oftalmologia y Cirugia Plastica	El Escalón	San Salvador
United States	ACE Eyecare, Inc	Bakersfield	California

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Surgical Vision, Inc.

Countries where clinical trial is conducted

United States,  El Salvador, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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