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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Next Generation Phaco System | Experimental | VERITAS Vision System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johnson & Johnson Surgical Vision Clinical Trial | Johnson & Johnson Surgical Vision | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ACE Eyecare, Inc | Bakersfield | California | 93301 | United States | ||
| Grupo Oftalmo & Plastico, Centro de Oftalmologia y Cirugia Plastica |
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
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A total of 115 eyes of 79 subjects were enrolled and treated at 2 sites by 6 investigators. Of these 79 subjects (115 eyes) , 36 subjects had bilateral (72 eyes) surgeries and 43 subjects had unilateral (43 eyes) surgeries.
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| ID | Title | Description |
|---|---|---|
| FG000 | Veritas Vision System | Next Generation Phaco System |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Veritas Vision System | Next Generation Phaco System |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | All Eyes treated with Veritas Vision System * 1 Surgeon rating was disqualified in Overall satisfaction with VERITAS Vision System, making N=114 | Posted | Number | 95% Confidence Interval | Proportion of Eyes | 1 day postoperative | Eyes | Eyes |
|
|
48 days
Analysis population include all 79 participants treated using the VERITAS Vision System. All adverse events (AEs), ocular and non-ocular, were monitored/assessed and planned to be reported for each eye separately.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Veritas Vision System | Next Generation Phaco System | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Posterior capsule rupture due to surgeon error | Surgical and medical procedures | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Clinical Science | Johnson & Johnson Surgical Vision | 7142478200 | LVarga17@ITS.JNJ.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 17, 2020 | Apr 26, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 2, 2020 | Apr 26, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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|
| El Escalón |
| San Salvador Department |
| El Salvador |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| Counts |
|---|
| Participants |
|
| Eyes |
|
|
| 79 |
| 1 |
| 79 |
| 0 |
| 79 |
The sponsor must review results communication prior to public release and can embargo communications regarding trial results at anytime.