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Clinical Evaluation of the Next Generation Phaco System (ALPINE)

Primary Purpose

Cataract

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
VERITAS Vision System
Sponsored by
Johnson & Johnson Surgical Vision, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • ACE Eyecare, Inc
  • Grupo Oftalmo & Plastico, Centro de Oftalmologia y Cirugia Plastica

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Next Generation Phaco System

Arm Description

VERITAS Vision System

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
April 1, 2020
Last Updated
June 13, 2022
Sponsor
Johnson & Johnson Surgical Vision, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04332640
Brief Title
Clinical Evaluation of the Next Generation Phaco System
Acronym
ALPINE
Official Title
Clinical Investigation of the Next Generation Phaco System (VERITAS Vision System)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
September 28, 2020 (Actual)
Primary Completion Date
May 1, 2021 (Actual)
Study Completion Date
May 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson Surgical Vision, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Next Generation Phaco System
Arm Type
Experimental
Arm Description
VERITAS Vision System
Intervention Type
Device
Intervention Name(s)
VERITAS Vision System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of Eyes With Surgeon Satisfaction Rating Score of 4 or 5
Description
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)
Time Frame
1 day postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johnson & Johnson Surgical Vision Clinical Trial
Organizational Affiliation
Johnson & Johnson Surgical Vision
Official's Role
Study Director
Facility Information:
Facility Name
ACE Eyecare, Inc
City
Bakersfield
State/Province
California
ZIP/Postal Code
93301
Country
United States
Facility Name
Grupo Oftalmo & Plastico, Centro de Oftalmologia y Cirugia Plastica
City
El Escalón
State/Province
San Salvador
Country
El Salvador

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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
IPD Sharing URL
http://yoda.yale.edu

Learn more about this trial

Clinical Evaluation of the Next Generation Phaco System

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