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
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