CataractsNCT06250322
A Multicenter, Observational, Single Arm Study of the TECNIS Presbyopia-correcting Intraocular Lens
An observational study of Cataracts, run by Johnson & Johnson Surgical Vision, Inc. at 20 sites in 8 countries.
Trial summary
Ambispective post-market data collection on visual symptoms, patient satisfaction and surgeon experience with the TECNIS PC IOL. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cataracts
- What is being tested?
- Intervention
- Type of treatment
- Medical device
- How many people
- 307 participants
- Where
- 20 sitesin 8 countries
- Study dates
- 10 Apr 2024to 30 Jun 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: A pre-existing population of subjects bilaterally implanted with the PC IOL at approximately 20 sites in Europe and Asia Pacific. Bilateral pseudophakic subjects implanted with the TECNIS PC IOL will be enrolled.
Who may be able to join
- Patients who are bilaterally implanted with TECNIS PC IOL and are at least 45 days postoperative from their second eye surgery
- Clear intraocular media
- Signed informed consent and data protection documentation
- Availability, willingness, ability, and sufficient cognitive awareness to comply with examination procedures
- Ability to understand, read, and write English or the local language in which the informed consent and questionnaires are provided
Who cannot join
- Subjects with ongoing adverse events that might impact outcomes during the study
- Use of systemic or ocular medication that may affect vision
- Acute or chronic disease or condition, ocular trauma or surgery that may confound results
- Patients with amblyopia, strabismus, nystagmus
- Concurrent participation in another clinical trial
Trial locations and contacts
20 sites in 8 countries.
20 sites in 8 countries
Australia4 sites
Sunshine Eye Clinic
Birtinya, Queensland, 4575
Vision Eye Institute
Chatswood, New South Wales, 2067
Lions Eye Institute
Nedlands, Western Australia, 6009
The Queensland Eye Institute Foundation
Woolloongabba, Queensland, 4102
India4 sites
Narayana Nethralaya
Bengaluru
The Eye Foundation
Coimbatore
Centre for Sight Eye Institute
New Delhi, 110029
All India Institute of Medical Sciences (AIIMS)
New Delhi
Spain3 sites
Clinica Oftalmologica Diez del Corral
Madrid, 28016
Mirzana IOA
Madrid, 28035
Vithas Alicante
Madrid, 28043
France2 sites
CHU Morvan Brest
Brest, 29609
Clinique Juge Marseille
Marseille, 13008
Germany2 sites
Augenklinik Ahaus GmbH & Co. KG
Ahaus, 48683
Augenklinik Dardenne
Bonn, 53177
Netherlands2 sites
Oogziekenhuis Rotterdam
Rotterdam, 3011 BH
ETZ
Tilburg, 5022 GC
Austria1 site
Vienna Institute for Research in Ocular Surgery - A Karl-Landsteiner-Institute
Vienna, 1140
About this study
Ambispective post-market data collection on visual symptoms, patient satisfaction and surgeon experience with the TECNIS PC IOL.
- Conditions
- Cataracts
- Being tested
- Intervention
- Medical subject headings
- 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 study. However, data will be collected from medical records of patients who have been treated with the subject device of this study.
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Symptoms
Patient questionnaires
Measured: 3month postoperative
Surgeon Experience
Questionnaire
Measured: 3month postoperative
Visual Acuity
Visual Acuity will be collected with standard clinical charts.
Measured: 3month postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start10 Apr 2024
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractsStudies 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
- Other
- Enrolment
- 307 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
- NCT06250322
- Sponsor's protocol ID
- PCOL204APME
- Status last verified
- Jun 2026
- First submitted
- 1 Feb 2024
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- 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 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Observational, Single Arm Study of the TECNIS Presbyopia-correcting Intraocular Lens
- ClinicalTrials.gov ID
- NCT06250322
- Acronym / sponsor ID
- PCOL204APME
- Conditions
- Cataracts
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 307 participants (actual)
- Lead sponsor
- Johnson & Johnson Surgical Vision, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Apr 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 9 Feb 2024 (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.
Ambispective post-market data collection on visual symptoms, patient satisfaction and surgeon experience with the TECNIS PC IOL.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A pre-existing population of subjects bilaterally implanted with the PC IOL at approximately 20 sites in Europe and Asia Pacific. Bilateral pseudophakic subjects implanted with the TECNIS PC IOL will be enrolled.
Key inclusion criteria (5 listed)
- Patients who are bilaterally implanted with TECNIS PC IOL and are at least 45 days postoperative from their second eye surgery
- Clear intraocular media
- Signed informed consent and data protection documentation
- Availability, willingness, ability, and sufficient cognitive awareness to comply with examination procedures
- Ability to understand, read, and write English or the local language in which the informed consent and questionnaires are provided
Key exclusion criteria (5 listed)
- Subjects with ongoing adverse events that might impact outcomes during the study
- Use of systemic or ocular medication that may affect vision
- Acute or chronic disease or condition, ocular trauma or surgery that may confound results
- Patients with amblyopia, strabismus, nystagmus
- Concurrent participation in another clinical trial
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 study. However, data will be collected from medical records of patients who have been treated with the subject device of this study. | Device | – |
Primary outcome
Visual Symptoms
Time frame: 3month postoperative
Patient questionnaires
Surgeon Experience
Time frame: 3month postoperative
Questionnaire
Visual Acuity
Time frame: 3month postoperative
Visual Acuity will be collected with standard clinical charts.
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 5 Jun 2026.
- 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.
20 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataracts, run by Johnson & Johnson Surgical Vision, Inc. at 20 sites in 8 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 5 inclusion and 5 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 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Australia, India, Spain, France, Germany and 3 more countries. 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?
Visual Symptoms (time frame: 3month postoperative). The study lists 3 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 5 Jun 2026.