NCT04332640

Clinical Evaluation of the Next Generation Phaco System

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: Johnson & Johnson Surgical Vision, Inc. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-09-28
• Primary completion: 2021-05-01
• Completion: 2021-05-01
• First posted: 2020-04-02
• Last updated: 2022-06-15
• Results posted: 2022-06-01

Locations

2 sites across 2 countries: United States, El Salvador

Regulatory

• FDA-regulated device study