NCT05394324

Brief Summary

Retrospective collection of data from medical records, multicenter, post-market clinical follow-up study.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,674

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2022

Typical duration for all trials

Geographic Reach
3 countries

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 27, 2022

Completed
25 days until next milestone

Study Start

First participant enrolled

June 21, 2022

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
Last Updated

July 20, 2025

Status Verified

July 1, 2025

Enrollment Period

2.9 years

First QC Date

May 24, 2022

Last Update Submit

July 18, 2025

Conditions

Refractive ErrorGlaucomaCataractsClear Lens Exchange

Outcome Measures

Primary Outcomes (2)

  • Incidence of Adverse Events

    incidence of adverse events that are specified in the ISO 11979-7 Safety and Performance Endpoints.

    up to 12 months post-operation

  • BCDVA

    The proportion of eyes achieving 20/40 or better BCDVA.

    up to 12 months post-operation

Interventions

InterventionDEVICE

No study treatments will be administered during this retrospective study. However, data will be collected from medical records of patients who have been treated with subject devices of this study.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who have been implanted with and/or have undergone ophthalmic surgery using commercial JJSV product(s).

You may qualify if:

  • Patients who have been implanted with and/or undergone ophthalmic surgery using targeted JJSV products
  • Status post ophthalmic surgery between 1 day and 24 months for Year 1. Subsequent years after Year 1 will be between 1 day and 18 months.

You may not qualify if:

  • Concurrent participation (during the retrospective follow-up period) in an interventional (drug, device, biologic, etc.) clinical trial
  • Use of surgical devices not in accordance with the product labeling or indications for use
  • Degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that cause visual acuity losses to a level worse than 0.2 logMAR (0.63 decimal, 6/9.5 or 20/32 Snellen) during the retrospective data collection period
  • Use of systemic or ocular medications that may affect vision during the retrospective data collection period
  • Known ocular disease or pathology that, in the opinion of the investigator may confound study findings during the retrospective data collection period
  • Pregnancy, lactating, or other condition associated with hormonal fluctuation that could lead to refractive changes during the retrospective data collection period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Trinity Research Group, LLC

Dothan, Alabama, 36301, United States

Location

Empire Eye and Laser Center

Bakersfield, California, 93309, United States

Location

Chu Vision Institute

Bloomington, Minnesota, 55420, United States

Location

Valley Retina Institute

McAllen, Texas, 78503, United States

Location

Augenaerzte Gerl & Kollegen MVZ Ahaus GmbH

Ahaus, North Rhine-Westphalia, 48683, Germany

Location

Augenzentrum Erzgebirge

Zschopau, Saxony, 09405, Germany

Location

Augentagesklinik Spreebogen Berlin GbR

Berlin, 10559, Germany

Location

Clinica Vistahermosa

Alicante, Alacant, 03015, Spain

Location

Hospital La Arruzafa

Córdoba, Andalusia, 14012, Spain

Location

Instituto Universitario de Oftalmobiologia Aplicada

Valladolid, CL, 47011, Spain

Location

Hosp. De La Santa Creu I Sant Pau

Barcelona, CT, 08025, Spain

Location

Hospital Clinico San Carlos

Madrid, MD, 28040, Spain

Location

Clinica Oftalvist

Madrid, 28008, Spain

Location

MeSH Terms

Conditions

Refractive ErrorsGlaucomaCataract

Interventions

Methods

Condition Hierarchy (Ancestors)

Eye DiseasesOcular HypertensionLens Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Johnson & Johnson Surgical Vision, Inc. Clinical Trial

    Johnson & Johnson Surgical Vision, Inc.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2022

First Posted

May 27, 2022

Study Start

June 21, 2022

Primary Completion

May 31, 2025

Study Completion

May 31, 2025

Last Updated

July 20, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

Johnson \& Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) 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

More information

Locations

DE(3)US(4)ES(6)