NCT04332640|CompletedResultsFDA Device
Clinical Evaluation of the Next Generation Phaco System
ALPINE
Clinical Investigation of the Next Generation Phaco System (VERITAS Vision System)
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Sponsor study identifier
interventional
79
2 countries
2
Study Start
September 28, 2020
Actual (reported)Primary Completion
May 1, 2021
Actual (reported)Study Completion
May 1, 2021
Actual (reported)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-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 1, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 1, 2020
Actual (reported)April 2, 2020
Actual (reported)September 28, 2020
Actual (reported)May 1, 2021
Actual (reported)May 1, 2021
Actual (reported)June 1, 2022
Actual (reported)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
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
ACE Eyecare, Inc
Bakersfield, California, 93301, United States
Grupo Oftalmo & Plastico, Centro de Oftalmologia y Cirugia Plastica
El Escalón, San Salvador Department, El Salvador
Johnson & Johnson Surgical Vision Clinical Trial
Johnson & Johnson Surgical Vision
79 participants (actual enrollment reported by the registry).
First Submitted
April 1, 2020
First Posted
April 2, 2020
Study Start
September 28, 2020
Actual (reported)A Clinical Study Comparing Postoperative Outcomes Between the TECNIS Intraocular Lens.
Contact the study team to confirm eligibility.
Primary Completion
May 1, 2021
Actual (reported)Study Completion
May 1, 2021
Actual (reported)Last Updated
June 15, 2022
Results First Posted
June 1, 2022
Record last verified: 2022-06
Johnson \& Johnson Medical Devices Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA project site at http://yoda.yale.edu
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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