Refractive ErrorNCT05394324
A Post-market Clinical Study to Collect Safety and Performance Data on Johnson & Johnson Surgical Vision Products
An observational study of Refractive Error and Glaucoma, run by Johnson & Johnson Surgical Vision, Inc. at 13 sites in 3 countries.
Trial summary
Retrospective collection of data from medical records, multicenter, post-market clinical follow-up study. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Refractive Error, Glaucoma, Cataracts
- What is being tested?
- Intervention
- Type of treatment
- Medical device
- How many people
- 1,674 participants
- Where
- 13 sitesin 3 countries
- Study dates
- 21 Jun 2022to 31 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who have been implanted with and/or have undergone ophthalmic surgery using commercial JJSV product(s).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
13 sites in 3 countries.
13 sites in 3 countries
Spain6 sites
Clinica Vistahermosa
Alicante, Alacant, 03015
Hosp. De La Santa Creu I Sant Pau
Barcelona, CT, 08025
Hospital La Arruzafa
Córdoba, Andalusia, 14012
Hospital Clinico San Carlos
Madrid, MD, 28040
Clinica Oftalvist
Madrid, 28008
Instituto Universitario de Oftalmobiologia Aplicada
Valladolid, CL, 47011
United States4 sites
Empire Eye and Laser Center
Bakersfield, California, 93309
Chu Vision Institute
Bloomington, Minnesota, 55420
Trinity Research Group, LLC
Dothan, Alabama, 36301
Valley Retina Institute
McAllen, Texas, 78503
Germany3 sites
Augenaerzte Gerl & Kollegen MVZ Ahaus GmbH
Ahaus, North Rhine-Westphalia, 48683
Augentagesklinik Spreebogen Berlin GbR
Berlin, 10559
Augenzentrum Erzgebirge
Zschopau, Saxony, 09405
About this study
Retrospective collection of data from medical records, multicenter, post-market clinical follow-up study.
- Conditions
- Refractive Error, Glaucoma, Cataracts, Clear Lens Exchange
- Being tested
- Intervention
- Medical subject headings
- Refractive Errors, Glaucoma, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events
incidence of adverse events that are specified in the ISO 11979-7 Safety and Performance Endpoints.
Measured: up to 12 months post-operation
BCDVA
The proportion of eyes achieving 20/40 or better BCDVA.
Measured: up to 12 months post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2022
- Study start21 Jun 2022
- Primary completion31 May 2025
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractive ErrorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,674 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Surgical Vision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson Surgical Vision, Inc. Clinical Trial, Study director, Johnson & Johnson Surgical Vision, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05394324
- Sponsor's protocol ID
- JJSV301PMCF
- Status last verified
- Jul 2025
- First submitted
- 24 May 2022
- Last updated
- 20 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-market Clinical Study to Collect Safety and Performance Data on Johnson & Johnson Surgical Vision Products
- ClinicalTrials.gov ID
- NCT05394324
- Acronym / sponsor ID
- JJSV301PMCF
- Conditions
- Refractive Error, Glaucoma, Cataracts, Clear Lens Exchange
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,674 participants (actual)
- Lead sponsor
- Johnson & Johnson Surgical Vision, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Jun 2022 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 27 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Retrospective collection of data from medical records, multicenter, post-market clinical follow-up study.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who have been implanted with and/or have undergone ophthalmic surgery using commercial JJSV product(s).
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterventionNo 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. | Device | – |
Primary outcome
Incidence of Adverse Events
Time frame: up to 12 months post-operation
incidence of adverse events that are specified in the ISO 11979-7 Safety and Performance Endpoints.
BCDVA
Time frame: up to 12 months post-operation
The proportion of eyes achieving 20/40 or better BCDVA.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2025.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johnson & Johnson Surgical Vision, Inc. Clinical Trial study director
Johnson & Johnson Surgical Vision, Inc.
13 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Refractive Error and Glaucoma, run by Johnson & Johnson Surgical Vision, Inc. at 13 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Spain, United States, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (time frame: up to 12 months post-operation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2025.