CataractNCT05036070
Proof-of-concept Study for a New Intraocular Lens, MODEL C0001
A study testing Model C0001 and Model ZCB00 in people with Cataract, run by Johnson & Johnson Surgical Vision, Inc. at 2 sites in France.
Trial summary
This study is a 12-month, prospective, 2-arm (1 test \& 1 control), randomized (1 test:1 control), bilateral, subject/evaluator-masked clinical investigation of the EPV IOL versus the standard TECNIS monofocal control IOL. Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Cataract
- What is being tested?
- Model C0001 and Model ZCB00
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 2 sitesFrance
- Study dates
- 18 Nov 2021to 24 Apr 2024
- 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:
Show all 12Show fewer
- 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 C0001 IOL or +16.0 D to +28.0 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;
Show all 20Show fewer
- 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;
- Motion Sickness Susceptibility Questionnaire Short-form (MSSQ-Short) score of ≥ 25;
- 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
This study is a 12-month, prospective, 2-arm (1 test \& 1 control), randomized (1 test:1 control), bilateral, subject/evaluator-masked clinical investigation of the EPV IOL versus the standard TECNIS monofocal control IOL.
The study will be conducted at a minimum of one to a maximum of five sites in France, with a total of 40 evaluable subjects for the investigational lens group and 40 evaluable subjects for the control lens group participating in the sub-study. The peripheral and functional testing will be conducted on a sub-group of subjects who achieve binocular uncorrected distance visual acuity (UCDVA) of 0.2 logMAR or better and/or are able to perform the driving simulator-sickness testing as determined by patient response to the SSQ (Appendix D) at the first 1-month visit.
The eye implanted first will be considered the primary study eye (first eye). Subjects will be randomized to either the investigational IOL Model C0001 or the control IOL Model ZCB00 in both eyes.
- Conditions
- Cataract
- Being tested
- Model C0001, Model ZCB00
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Model C0001Device
Investigational intraocular lens replaces the natural lens removed during cataract surgery in both eyes.
Model ZCB00Device
Control intraocular lens replaces the natural lens removed during cataract surgery in both eyes.
| Study group | Role | What they receive |
|---|---|---|
| Study Lens | Experimental | Model C0001 Receives: Device: Model C0001 |
| Control Lens | Active comparator | Model ZCB00 Receives: Device: Model ZCB00 |
What is being measured
The primary outcome is the main question the study is designed to answer.
MONOCULAR, PERIPHERAL REFRACTIVE ERROR
Measured: 1 month postoperative
MONOCULAR, PHOTOPIC BCDVA AT 4 M
Measured: 1 month postoperative
Adverse Events rates
Measured: 12 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start18 Nov 2021
- Primary completion24 Apr 2024
- Study completion24 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 113 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 Clinical Trials, Study director, Johnson & Johnson Surgical Vision
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05036070
- Sponsor's protocol ID
- PCOL-103-ARPV
- Status last verified
- May 2025
- First submitted
- 26 Aug 2021
- Last updated
- 23 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Johnson \& Johnson Medical Devices Companies have an agreement with the Yale Open Data Access (YODA) Project 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 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof-of-concept Study for a New Intraocular Lens, MODEL C0001
- ClinicalTrials.gov ID
- NCT05036070
- Acronym / sponsor ID
- PCOL-103-ARPV
- Conditions
- Cataract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Johnson & Johnson Surgical Vision, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Nov 2021 (actual)
- Primary completion
- 24 Apr 2024 (actual)
- Study completion
- 24 Apr 2024 (actual)
- First posted
- 5 Sep 2021 (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.
This study is a 12-month, prospective, 2-arm (1 test \& 1 control), randomized (1 test:1 control), bilateral, subject/evaluator-masked clinical investigation of the EPV IOL versus the standard TECNIS monofocal control IOL.
The study will be conducted at a minimum of one to a maximum of five sites in France, with a total of 40 evaluable subjects for the investigational lens group and 40 evaluable subjects for the control lens group participating in the sub-study. The peripheral and functional testing will be conducted on a sub-group of subjects who achieve binocular uncorrected distance visual acuity (UCDVA) of 0.2 logMAR or better and/or are able to perform the driving simulator-sickness testing as determined by patient response to the SSQ (Appendix D) at the first 1-month visit.
The eye implanted first will be considered the primary study eye (first eye). Subjects will be randomized to either the investigational IOL Model C0001 or the control IOL Model ZCB00 in both eyes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Lens | Experimental | Device: Model C0001Model C0001 |
| Control Lens | Active comparator | Device: Model ZCB00Model ZCB00 |
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 (20 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 C0001 IOL or +16.0 D to +28.0 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 C0001Investigational intraocular lens replaces the natural lens removed during cataract surgery in both eyes. | Device | Study Lens |
| Model ZCB00Control intraocular lens replaces the natural lens removed during cataract surgery in both eyes. | Device | Control Lens |
Primary outcome
MONOCULAR, PERIPHERAL REFRACTIVE ERROR
Time frame: 1 month postoperative
MONOCULAR, PHOTOPIC BCDVA AT 4 M
Time frame: 1 month postoperative
Adverse Events rates
Time frame: 12 months postoperative
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 23 May 2025.
- Individual participant dataSharing planned: Yes. Johnson \& Johnson Medical Devices Companies have an agreement with the Yale Open Data Access (YODA) Project 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
Related trials for Cataract
RecruitingObservational study
Capella Scientia Development Study
Cataract
Recruiting
Clareon TruPlus Study
Aphakia, Astigmatism
RecruitingObservational study
Anterior Segment Anatomy Assessed by Swept-Source OCT in Ocular Surgery Patients
Cataract, Primary Angle-Closure Glaucoma
Active, not recruitingObservational study
Age-Related Eye Disease Study (AREDS) Follow-Up
Age-Related Macular Degeneration, Cataract
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
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 Clinical Trials study director
Johnson & Johnson Surgical Vision
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 C0001 and Model ZCB00 in people with Cataract, 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 20 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 23 May 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?
MONOCULAR, PERIPHERAL REFRACTIVE ERROR (time frame: 1 month 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 23 May 2025.