CataractsNCT05531292
PROOF-OF-CONCEPT STUDY FOR NEW INTRAOCULAR LENS, MODEL C0002
A study testing Model C0002 and Model ZCB00/DCB00 in people with Cataracts, run by Johnson & Johnson Surgical Vision, Inc. at 2 sites in France.
Trial summary
Prospective, two-arm, randomized, bilateral, subject/evaluator-masked clinical study to evaluate the distance visual acuity, peripheral refractive error and functional vision of the EPV IOL compared to a standard monofocal control IOL. Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Cataracts
- What is being tested?
- Model C0002 and Model ZCB00/DCB00
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 2 sitesFrance
- Study dates
- 22 Nov 2022to 20 May 2025
- Phase
- Interventional
- 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 60 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of study population between 60-75 years;
- Bilateral cataracts for which cataract extraction and posterior chamber IOL implantation have been planned for both eyes;
- Cataractous lens changes, as demonstrated by best-corrected distance visual acuity (BCDVA) of 0.50 decimal or worse (6/12 or 20/40 Snellen) either with or without a glare source present (e.g., Brightness Acuity Tester) or with significant cataract related visual symptoms in the opinion of the investigator;
- Potential postoperative best-corrected distance visual acuity (BCDVA) of 0.66 decimal (6/9 or 20/30 Snellen) or better;
- Drives a car at least 1-2 times per month;
- Corneal astigmatism:
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- Normal corneal topography
- Predicted postoperative residual refractive cylinder based on a toric IOL calculator, taking surgically induced astigmatism (SIA) into account and using the posterior corneal astigmatism (PCA) option, must be less than 1.00 D in both eyes.
- Clear intraocular media other than cataract in each eye;
- Availability, willingness, 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, read, and write in French.
Who cannot join
- Requiring an intraocular lens power needed to achieve emmetropia (spherical equivalent ± 0.50 D) outside the available range of +18.0 D to +30.0 D for the Model C0002 IOL or +16.5 D to +27.5 D for the Model ZCB00 IOL;
- Pupil abnormalities (non-reactive, fixed pupils, or abnormally-shaped pupils);
- Irregular corneal astigmatism;
- Recent ocular trauma or ocular surgery that is not resolved/stable or may affect visual outcomes or increase risk to the subject;
- Prior corneal refractive (LASIK, LASEK, RK, PRK, etc.) or intraocular surgery;
- Subjects who may be expected to require retinal laser treatment during the study;
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- Corneal abnormalities such as stromal, epithelial or endothelial dystrophies that are predicted to cause visual acuity losses to a level of worse than 0.66 decimal (6/9 or 20/30 Snellen) during the study;
- Inability to achieve keratometric corneal stability preoperatively as a result of recent contact lens usage;
- Subjects with diagnosed degenerative visual disorders (e.g., retinal disorders such as macular degeneration) that are predicted to cause visual acuity losses to a level worse than 0.66 decimal (6/9 or 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 or tilt, such as pseudoexfoliation, trauma, or posterior capsule defects;
- Use of systemic or ocular medications that may affect vision;
- Prior, current, or anticipated use during the course of the 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);
- Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.);
- 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.
- Neurological or neurodegenerative disorders that affect locomotion and cognitive function (e.g., Muscular disorders, Parkinson's disease, Alzheimer's disease etc.);
- Use of mobility aids, any injury or condition that may affect walking;
- Subject has condition(s) associated with the fluctuation of hormones that could lead to refractive changes;
- Concurrent participation in any other clinical trial or participation within 30 days prior to the preoperative visit.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre Hospitalier National d'Ophtalmologie
Paris, Île-de-France Region, 75012
Rothschild Foundation Hospital
Paris, Île-de-France Region, 75019
About this study
Prospective, two-arm, randomized, bilateral, subject/evaluator-masked clinical study to evaluate the distance visual acuity, peripheral refractive error and functional vision of the EPV IOL compared to a standard monofocal control IOL.
- Conditions
- Cataracts
- Being tested
- Model C0002, 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.
Model C0002Device
Eligible subjects will be randomized in a 1:1 ratio to the investigational IOL Model C0002 in both eyes for the duration of the study.
Model ZCB00/DCB00Device
Eligible subjects will be randomized in a 1:1 ratio to the control IOL Model ZCB00 in both eyes for the duration of the study.
| Study group | Role | What they receive |
|---|---|---|
| Study Lens | Experimental | investigational IOL Model C0002 Receives: Device: Model C0002 |
| Control Lens | Active comparator | control IOL Model ZCB00/DCB00 Receives: Device: Model ZCB00/DCB00 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Refractive Error
Ocular refractive error, including defocus and astigmatism, will be measured using an autorefractor instrument.
Measured: within 14 days of completion of 1-month follow-up
MONOCULAR, PHOTOPIC BCDVA AT 4 M
Distance visual acuity will be measured postoperatively at 100% contrast under photopic lighting conditions (85 cd/m2, 80-110 cd/m2 acceptable).
Measured: within 14 days of completion of 1-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start22 Nov 2022
- Primary completion20 May 2025
- Study completion20 May 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 106 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
- NCT05531292
- Sponsor's protocol ID
- PCOL106APV2
- Status last verified
- Jul 2025
- First submitted
- 2 Sep 2022
- Last updated
- 20 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- 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
- PROOF-OF-CONCEPT STUDY FOR NEW INTRAOCULAR LENS, MODEL C0002
- ClinicalTrials.gov ID
- NCT05531292
- Acronym / sponsor ID
- PCOL106APV2
- Conditions
- Cataracts
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Johnson & Johnson Surgical Vision, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Nov 2022 (actual)
- Primary completion
- 20 May 2025 (actual)
- Study completion
- 20 May 2025 (actual)
- First posted
- 7 Sep 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.
Prospective, two-arm, randomized, bilateral, subject/evaluator-masked clinical study to evaluate the distance visual acuity, peripheral refractive error and functional vision of the EPV IOL compared to a standard monofocal control 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 |
|---|---|---|
| Study Lens | Experimental | Device: Model C0002investigational IOL Model C0002 |
| Control Lens | Active comparator | Device: Model ZCB00/DCB00control IOL Model ZCB00/DCB00 |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age of study population between 60-75 years;
- Bilateral cataracts for which cataract extraction and posterior chamber IOL implantation have been planned for both eyes;
- Cataractous lens changes, as demonstrated by best-corrected distance visual acuity (BCDVA) of 0.50 decimal or worse (6/12 or 20/40 Snellen) either with or without a glare source present (e.g., Brightness Acuity Tester) or with significant cataract related visual symptoms in the opinion of the investigator;
- Potential postoperative best-corrected distance visual acuity (BCDVA) of 0.66 decimal (6/9 or 20/30 Snellen) or better;
- Drives a car at least 1-2 times per month;
Key exclusion criteria (19 listed)
- Requiring an intraocular lens power needed to achieve emmetropia (spherical equivalent ± 0.50 D) outside the available range of +18.0 D to +30.0 D for the Model C0002 IOL or +16.5 D to +27.5 D for the Model ZCB00 IOL;
- Pupil abnormalities (non-reactive, fixed pupils, or abnormally-shaped pupils);
- Irregular corneal astigmatism;
- Recent ocular trauma or ocular surgery that is not resolved/stable or may affect visual outcomes or increase risk to the subject;
- Prior corneal refractive (LASIK, LASEK, RK, PRK, etc.) or intraocular surgery;
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 |
|---|---|---|
| Model C0002Eligible subjects will be randomized in a 1:1 ratio to the investigational IOL Model C0002 in both eyes for the duration of the study. | Device | Study Lens |
| Model ZCB00/DCB00Eligible subjects will be randomized in a 1:1 ratio to the control IOL Model ZCB00 in both eyes for the duration of the study. | Device | Control Lens |
Primary outcome
Postoperative Refractive Error
Time frame: within 14 days of completion of 1-month follow-up
Ocular refractive error, including defocus and astigmatism, will be measured using an autorefractor instrument.
MONOCULAR, PHOTOPIC BCDVA AT 4 M
Time frame: within 14 days of completion of 1-month follow-up
Distance visual acuity will be measured postoperatively at 100% contrast under photopic lighting conditions (85 cd/m2, 80-110 cd/m2 acceptable).
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Model C0002 and Model ZCB00/DCB00 in people with Cataracts, run by Johnson & Johnson Surgical Vision, Inc. at 2 sites in France.
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 12 inclusion and 19 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 2 sites in France. 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?
Postoperative Refractive Error (time frame: within 14 days of completion of 1-month follow-up). 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.