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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04332640
Other study ID # ALPI-101-SYST
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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