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CompletedNCT05394324Updated Jul 20, 2025

A Post-market Clinical Study to Collect Safety and Performance Data on Johnson & Johnson Surgical Vision Products

An observational study in Refractive Error, Glaucoma and Cataracts, sponsored by Johnson & Johnson Surgical Vision, Inc.. Completed at 13 sites in 3 countries. Per ClinicalTrials.gov, last updated 2025-07-20.

Sponsored by Johnson & Johnson Surgical Vision, Inc. · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
1,674
Sex
All
01

Study summary

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

02

Conditions studied

  • Refractive Error
  • Glaucoma
  • Cataracts
  • Clear Lens Exchange
03

In context

Refractive Errors

413 studies on the registry are indexed under Refractive Errors; 62 are open to participants now.

This study's enrollment of 1,674 is above the median of 150 across 107 observational studies indexed under Refractive Errors.

Browse Refractive Errors studies →

Lead sponsor

Johnson & Johnson Surgical Vision, Inc. is the lead sponsor of 36 studies on the registry; 1 is open to participants now.

Of its 15 completed or terminated interventional studies of FDA-regulated products, 13 (87%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

  1. Patients who have been implanted with and/or undergone ophthalmic surgery using targeted JJSV products
  2. 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.

Exclusion criteria

Exclusion Criteria:

  1. Concurrent participation (during the retrospective follow-up period) in an interventional (drug, device, biologic, etc.) clinical trial
  2. Use of surgical devices not in accordance with the product labeling or indications for use
  3. 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
  4. Use of systemic or ocular medications that may affect vision during the retrospective data collection period
  5. Known ocular disease or pathology that, in the opinion of the investigator may confound study findings during the retrospective data collection period
  6. Pregnancy, lactating, or other condition associated with hormonal fluctuation that could lead to refractive changes during the retrospective data collection period.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
1,674 participants (actual)
Patient registry
No

Interventions

  • DeviceIntervention

    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.

06

What researchers measure

Primary outcomes

  1. Incidence of Adverse Events

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

    Time frame: up to 12 months post-operation

  2. BCDVA

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

    Time frame: up to 12 months post-operation

07

Study locations

13 sites
  • Trinity Research Group, LLC
    Dothan, Alabama 36301, United States
  • Empire Eye and Laser Center
    Bakersfield, California 93309, United States
  • Chu Vision Institute
    Bloomington, Minnesota 55420, United States
  • Valley Retina Institute
    McAllen, Texas 78503, United States
  • Augenaerzte Gerl & Kollegen MVZ Ahaus GmbH
    Ahaus, North Rhine-Westphalia 48683, Germany
  • Augenzentrum Erzgebirge
    Zschopau, Saxony 09405, Germany
  • Augentagesklinik Spreebogen Berlin GbR
    Berlin, 10559, Germany
  • Clinica Vistahermosa
    Alicante, Alacant 03015, Spain
  • Hospital La Arruzafa
    Córdoba, Andalusia 14012, Spain
  • Instituto Universitario de Oftalmobiologia Aplicada
    Valladolid, CL 47011, Spain
  • Hosp. De La Santa Creu I Sant Pau
    Barcelona, CT 08025, Spain
  • Hospital Clinico San Carlos
    Madrid, MD 28040, Spain
  • Clinica Oftalvist
    Madrid, 28008, Spain
08

References and documents

Individual participant data

Plan to share: Yes — 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

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05394324
Lead sponsor
Johnson & Johnson Surgical Vision, Inc.
Responsible party
Sponsor
First posted
May 27, 2022
Start date
Jun 21, 2022
Primary completion
May 31, 2025
Completion
May 31, 2025
Last update
Jul 20, 2025

Study contacts

Johnson & Johnson Surgical Vision, Inc. Clinical Trial
study director · Johnson & Johnson Surgical Vision, Inc.

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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