CataractsNCT06377514
Clinical Investigation of the TECNIS® Next-Generation Intraocular Lens
A study testing Test IOL Model DEN00V in people with Cataracts, run by Johnson & Johnson Surgical Vision, Inc. at 9 sites in United States.
Trial summary
Prospective, multicenter, bilateral, interventional, controlled, masked (sponsor, subjects, and evaluators), randomized clinical trial. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataracts
- What is being tested?
- Test IOL Model DEN00V
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 245 participants
- Where
- 9 sitesUnited States
- Study dates
- 3 Jun 2024to 23 Apr 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- To be considered for enrollment in this study, patient must:
- be at least 22 years old
- have cataracts in both eyes
- sign the written informed consent
- be willing and able to comply with examination procedures
- understand, read and write English to complete informed consent and questionnaires
Show all 13Show fewer
- be available for study follow-up visits EXCLUSION CRITERIA
- Patient will not be eligible to take part in the study if:
- currently participating in any other clinical study or have participated in a clinical study during the last 30 days
- have a certain disease/illness, such as poorly controlled diabetes
- have certain ocular conditions, such as uncontrolled pressure in the eye
- taking medication that may affect vision
- pregnant, plan to become pregnant during the study, or are breastfeeding
Who cannot join
None listed.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Empire Eye & Laser Center
Bakersfield, California, 93309
Cleveland Eye Clinic
Brecksville, Ohio, 44141
OCLI Vision
Garden City, New York, 11530
Berkeley Eye Institute
Houston, Texas, 77027
Whitsett Vision Group
Houston, Texas, 77055
Levenson Eye Associates
Jacksonville, Florida, 32204
Parkhurst NuVision
San Antonio, Texas, 78229
Jones Eye Center
Sioux City, Iowa, 51104
Vance Thompson Vision
Sioux Falls, South Dakota, 57108
About this study
Prospective, multicenter, bilateral, interventional, controlled, masked (sponsor, subjects, and evaluators), randomized clinical trial.
- Conditions
- Cataracts
- Being tested
- Test IOL Model DEN00V, Control IOL Model DCB00
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test IOL Model DEN00VDevice
Eligible subjects will be randomized in a 1:1 ratio to receive either the Test IOL Model DEN00V or Control in both eyes for the duration of the study
Control IOL Model DCB00Device
Eligible subjects will be randomized in a 1:1 ratio to receive the control IOL Model DCB00 in both eyes for the duration of the study
| Study group | Role | What they receive |
|---|---|---|
| Test IOL | Experimental | DEN00V Receives: Device: Test IOL Model DEN00V |
| Control IOL | Active comparator | DCB00 Receives: Device: Control IOL Model DCB00 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monocular (First Eyes) Photopic DCIVA at 66 cm
Monocular photopic distance-corrected intermediate visual acuity (DCIVA) in logMAR at 66 cm for first eyes. Note that a lower logMAR value denotes better visual acuity. The difference in mean visual acuity is calculated as control group minus test group. This analysis was prespecified for the first operative eye.
Measured: 6 months
Monocular (First Eyes) Depth of Focus
Monocular depth of defocus where visual acuity is 0.20 logMAR or better (measured only negative direction from zero diopter) for first eyes. The data values reported represent the diopter of defocus at which the mean visual acuity for all participants crosses the 0.20 logMAR threshold. Therefore, the values reported are represented as a single value for each arm. This analysis was prespecified for the first operative eye.
Measured: 6 months
Monocular (First Eyes) Photopic BCDVA at 4m
Monocular photopic best-corrected distance visual acuity (BCDVA) in logMAR at 4 meters for the first eyes. Note that a lower logMAR value denotes better visual acuity. The difference in mean visual acuity is calculated as control group minus test group. This analysis was prespecified for the first operative eye.
Measured: 6 months
Monocular (First Eyes) Photopic DCVA at 100 cm
Monocular photopic Distance Corrected Visual Acuity (DCVA) in logMAR at 100 cm for first eyes. This analysis was prespecified for the first operative eye.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2024
- Study start3 Jun 2024
- Primary completion23 Apr 2025
- Study completion23 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 245 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
- NCT06377514
- Sponsor's protocol ID
- PCOL109PHNG
- Status last verified
- Jul 2026
- First submitted
- 17 Apr 2024
- Last updated
- 24 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation of the TECNIS® Next-Generation Intraocular Lens
- ClinicalTrials.gov ID
- NCT06377514
- Acronym / sponsor ID
- PCOL109PHNG
- Conditions
- Cataracts
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 245 participants (actual)
- Lead sponsor
- Johnson & Johnson Surgical Vision, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Jun 2024 (actual)
- Primary completion
- 23 Apr 2025 (actual)
- Study completion
- 23 Apr 2025 (actual)
- First posted
- 22 Apr 2024 (actual)
- Results
- Posted 17 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, multicenter, bilateral, interventional, controlled, masked (sponsor, subjects, and evaluators), randomized clinical trial.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test IOL | Experimental | Device: Test IOL Model DEN00VDEN00V |
| Control IOL | Active comparator | Device: Control IOL Model DCB00DCB00 |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- be at least 22 years old
- have cataracts in both eyes
- sign the written informed consent
- be willing and able to comply with examination procedures
- understand, read and write English to complete informed consent and questionnaires
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Test IOL Model DEN00VEligible subjects will be randomized in a 1:1 ratio to receive either the Test IOL Model DEN00V or Control in both eyes for the duration of the study | Device | Test IOL |
| Control IOL Model DCB00Eligible subjects will be randomized in a 1:1 ratio to receive the control IOL Model DCB00 in both eyes for the duration of the study | Device | Control IOL |
Primary outcome
Monocular (First Eyes) Photopic DCIVA at 66 cm
Time frame: 6 months
Monocular photopic distance-corrected intermediate visual acuity (DCIVA) in logMAR at 66 cm for first eyes. Note that a lower logMAR value denotes better visual acuity. The difference in mean visual acuity is calculated as control group minus test group. This analysis was prespecified for the first operative eye.
Monocular (First Eyes) Depth of Focus
Time frame: 6 months
Monocular depth of defocus where visual acuity is 0.20 logMAR or better (measured only negative direction from zero diopter) for first eyes. The data values reported represent the diopter of defocus at which the mean visual acuity for all participants crosses the 0.20 logMAR threshold. Therefore, the values reported are represented as a single value for each arm. This analysis was prespecified for the first operative eye.
Monocular (First Eyes) Photopic BCDVA at 4m
Time frame: 6 months
Monocular photopic best-corrected distance visual acuity (BCDVA) in logMAR at 4 meters for the first eyes. Note that a lower logMAR value denotes better visual acuity. The difference in mean visual acuity is calculated as control group minus test group. This analysis was prespecified for the first operative eye.
Monocular (First Eyes) Photopic DCVA at 100 cm
Time frame: 6 months
Monocular photopic Distance Corrected Visual Acuity (DCVA) in logMAR at 100 cm for first eyes. This analysis was prespecified for the first operative eye.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test IOL Model DEN00V in people with Cataracts, run by Johnson & Johnson Surgical Vision, Inc. at 9 sites in United States.
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 13 inclusion and 0 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 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. 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?
Yes. Results are posted in the registry (first posted 17 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Monocular (First Eyes) Photopic DCIVA at 66 cm (time frame: 6 months). The study lists 4 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 24 Aug 2026.