CataractsNCT05574959
Clinical Investigation of the TECNIS® Next-Generation Intraocular Lens, Model DEN00V
A study testing investigational IOL Model DEN00V in people with Cataracts, run by Johnson & Johnson Surgical Vision, Inc. at 10 sites in United States.
Trial summary
Prospective, multicenter, bilateral, masked (sponsor, subject and evaluator), randomized clinical trial to evaluate the safety and effectiveness of the TECNIS IOL, Model DEN00V in comparison to an aspheric monofocal IOL. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Cataracts
- What is being tested?
- investigational IOL Model DEN00V
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 243 participants
- Where
- 10 sitesUnited States
- Study dates
- 24 Oct 2022to 24 Oct 2023
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Minimum 22 years of age;
- Bilateral cataracts for which posterior chamber IOL implantation has been planned;
- Preoperative best corrected distance visual acuity (BCDVA) of 20/40 Snellen or worse with or without a glare source;
- Potential for postoperative BCDVA of 20/30 Snellen or better;
- Corneal astigmatism:
- Normal corneal topography;
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- ≤ 1.0 D of preoperative keratometric astigmatism;
- Clear intraocular media other than cataract;
- Availability, ability, willingness and sufficient cognitive awareness to comply with examination procedures;
- Signed informed consent and HIPAA authorization or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing countries;
- Ability to understand and respond to a questionnaire in English.
Who cannot join
- Requiring an intraocular lens power outside the available range of +14.0 D to +26.0 D;
- Any clinically significant pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils);
- Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.);
- Prior corneal refractive surgery (SMILE, LASIK, LASEK, RK, PRK, etc.);
- Corneal abnormalities such as stromal, epithelial or endothelial dystrophies that are predicted to cause visual acuity losses to a level worse than 20/30 Snellen during the study;
- Irregular corneal astigmatism;
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- Inability to achieve keratometric stability for contact lens wearers (as defined in preoperative procedures);
- History of intraocular surgery, including prophylactic peripheral iridotomies and peripheral laser retinal repairs;
- Recent ocular trauma that is not resolved/stable or may affect visual outcomes or increase risk to the subject;
- Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that are predicted to cause visual acuity losses to a level worse than 20/30 Snellen during the study;
- Subjects with conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration, including pseudoexfoliation, trauma, or posterior capsule defects;
- Use of systemic or ocular medications that may affect vision;
- Prior, current, or anticipated use during the 6-month study of tamsulosin or silodosin (e.g., Flomax, Flomaxtra, Rapaflo) that may, in the opinion of the investigator, confound the outcomes or increase the risk to the subject (e.g., poor dilation or a lack of adequate iris structure to perform standard cataract surgery);
- Poorly controlled diabetes;
- Acute, chronic, or uncontrolled systemic or ocular disease or illness that, in the opinion of the investigator, would increase the operative risk or confound the outcomes of the study (e.g., immunocompromised, connective tissue disease, suspected glaucoma, glaucomatous changes in the fundus or visual field, ocular inflammation, etc.). Note: controlled ocular hypertension without glaucomatous changes (optic nerve cupping and visual field loss) is acceptable;
- Known ocular disease or pathology that, in the opinion of the investigator:
- may affect visual acuity;
- may require surgical intervention during the study (macular degeneration, cystoid macular edema, diabetic retinopathy, uncontrolled glaucoma, etc.);
- may be expected to require retinal laser treatment or other surgical intervention during the study (macular degeneration, cystoid macular edema, diabetic retinopathy, etc.);
- Pregnancy, planned pregnancy, presently lactating or another condition associated with hormonal fluctuation that could lead to refractive changes;
- Concurrent participation or participation within 30 days prior to preoperative visit in any other clinical trial;
- Desire for monovision correction.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Empire Eye & Laser Center
Bakersfield, California, 93309
Cincinnati Eye Institute
Cincinnati, Ohio, 45242
OCLI Vision
Garden City, New York, 11530
Whitsett Vision Group
Houston, Texas, 77055
Southern California Eye Physicians and Associates
Long Beach, California, 90805
Carolina EyeCare Physicians, LLC
Mt. Pleasant, South Carolina, 29464
Focal Point Vision
San Antonio, Texas, 78209
Parkhurst NuVision
San Antonio, Texas, 78229
Jones Eye Center
Sioux City, Iowa, 51104
Wolstan & Goldberg Eye Associates
Torrance, California, 90505
About this study
Prospective, multicenter, bilateral, masked (sponsor, subject and evaluator), randomized clinical trial to evaluate the safety and effectiveness of the TECNIS IOL, Model DEN00V in comparison to an aspheric monofocal IOL.
- Conditions
- Cataracts
- Being tested
- investigational IOL Model DEN00V, control IOL Model ZCB00/DCB00
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
investigational IOL Model DEN00VDevice
Eligible subjects will be randomized in a 1:1 ratio to receive either the investigational IOL Model DEN00V or Control Model ZCB00/DCB00 in both eyes for the duration of the study.
control IOL Model ZCB00/DCB00Device
Eligible subjects will be randomized in a 1:1 ratio to receive either the investigational IOL Model DEN00V or Control Model ZCB00/DCB00 in both eyes for the duration of the study.
| Study group | Role | What they receive |
|---|---|---|
| Investigational Lens Device | Experimental | Investigational IOL Model DEN00V Receives: Device: investigational IOL Model DEN00V |
| Control Lens Device | Active comparator | Control IOL Model ZCB00/DCB00 Receives: Device: control IOL Model ZCB00/DCB00 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monocular DCIVA at 66cm for First Eyes
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 BCDVA at 4 Meters for First Eyes
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 Depth of Focus for First Eyes
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start24 Oct 2022
- Primary completion24 Oct 2023
- Study completion24 Oct 2023
Why it stopped: Business Decision
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 243 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
- NCT05574959
- Sponsor's protocol ID
- PCOL107AHNG
- Status last verified
- Jul 2026
- First submitted
- 7 Oct 2022
- Last updated
- 11 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 11 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, Model DEN00V
- ClinicalTrials.gov ID
- NCT05574959
- Acronym / sponsor ID
- PCOL107AHNG
- Conditions
- Cataracts
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business Decision
- Enrolment
- 243 participants (actual)
- Lead sponsor
- Johnson & Johnson Surgical Vision, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Oct 2022 (actual)
- Primary completion
- 24 Oct 2023 (actual)
- Study completion
- 24 Oct 2023 (actual)
- First posted
- 12 Oct 2022 (actual)
- Results
- Posted 11 Aug 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, masked (sponsor, subject and evaluator), randomized clinical trial to evaluate the safety and effectiveness of the TECNIS IOL, Model DEN00V in comparison to an aspheric monofocal IOL.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational Lens Device | Experimental | Device: investigational IOL Model DEN00VInvestigational IOL Model DEN00V |
| Control Lens Device | Active comparator | Device: control IOL Model ZCB00/DCB00Control IOL Model ZCB00/DCB00 |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Minimum 22 years of age;
- Bilateral cataracts for which posterior chamber IOL implantation has been planned;
- Preoperative best corrected distance visual acuity (BCDVA) of 20/40 Snellen or worse with or without a glare source;
- Potential for postoperative BCDVA of 20/30 Snellen or better;
- Corneal astigmatism:
Key exclusion criteria (22 listed)
- Requiring an intraocular lens power outside the available range of +14.0 D to +26.0 D;
- Any clinically significant pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils);
- Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.);
- Prior corneal refractive surgery (SMILE, LASIK, LASEK, RK, PRK, etc.);
- Corneal abnormalities such as stromal, epithelial or endothelial dystrophies that are predicted to cause visual acuity losses to a level worse than 20/30 Snellen during the study;
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 |
|---|---|---|
| investigational IOL Model DEN00VEligible subjects will be randomized in a 1:1 ratio to receive either the investigational IOL Model DEN00V or Control Model ZCB00/DCB00 in both eyes for the duration of the study. | Device | Investigational Lens Device |
| control IOL Model ZCB00/DCB00Eligible subjects will be randomized in a 1:1 ratio to receive either the investigational IOL Model DEN00V or Control Model ZCB00/DCB00 in both eyes for the duration of the study. | Device | Control Lens Device |
Primary outcome
Monocular DCIVA at 66cm for First Eyes
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 BCDVA at 4 Meters for First Eyes
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 Depth of Focus for First Eyes
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 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.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing investigational IOL Model DEN00V in people with Cataracts, run by Johnson & Johnson Surgical Vision, Inc. at 10 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 11 inclusion and 22 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: stopped early, as of the sponsor's last update on 11 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 10 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 11 Aug 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 DCIVA at 66cm for First Eyes (time frame: 6 Months). 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 11 Aug 2026.