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CataractNCT04890249

Clinical Investigation of Two Tecnis Investigational Lenses

A study testing Investigational IOL Model C1V000 and Investigational IOL Model C2V000 in people with Cataract and Corneal Astigmatism, run by Johnson & Johnson Surgical Vision, Inc. at 8 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is a 6-month, prospective, multicenter, randomized (1:1:1), subject-masked and evaluator-masked, bilateral clinical investigation of the TECNIS IOL Models C1V000 and C2V000 versus the TECNIS Eyhance™ Model ICB00 IOL. Read more about this study

Who is it for?
Ages 22 years and older
Conditions the study is for
Cataract, Corneal Astigmatism
What is being tested?
Investigational IOL Model C1V000 and Investigational IOL Model C2V000
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
221 participants
Where
8 sitesin 2 countries
Study dates
23 Jun 2021to 31 Jan 2023
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 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 or planned natural lens removal (due to immature cataract) for which phacoemulsification extraction and posterior 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
  • Corneal astigmatism:
  • Normal corneal topography
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  • Predicted postoperative corneal astigmatism of less than 1.00 D in both eyes, including posterior corneal astigmatism (PCA)
  • Clear intraocular media other than cataract
  • Signed informed consent for participation in the study and data protection
  • Availability, willingness, ability, and sufficient cognitive awareness to comply with examination procedures and study visits
  • Ability to understand, read, and write English or the local language in which the informed consent and questionnaires are provided.

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 (LASIK, LASEK, RK, PRK, etc.) or intraocular surgery, including prophylactic peripheral iridotomies and peripheral laser retinal repairs
  • Corneal abnormalities such as stromal, epithelial, or endothelial dystrophies (e.g., any observed guttata) 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
  • Irregular corneal astigmatism
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  • Inability to achieve keratometric stability for contact lens wearers
  • Recent ocular trauma or ocular surgery 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 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 6-month study of tamsulosin or silodosin (e.g., Flomax, Flomaxtra, Rapaflo) that may, in the opinion of the investigator, confound the outcome 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 outcome 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 course of 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 course of 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 60 days prior to preoperative visit in any other clinical trial
  • Desire for monovision correction.

Trial locations and contacts

8 sites in 2 countries.

8 sites in 2 countries

Australia7 sites

  • Sunshine Eye Clinic

    Birtinya, Queensland, 4575

  • personalEYES Pty. Ltd.

    Burwood, New South Wales, 2134

  • Vision Eye Institute

    Chatswood, New South Wales, 2067

  • Queensland Eye Institute

    South Brisbane, Queensland, 4101

  • George St Eye Centre

    Sydney, New South Wales, 2000

  • Bondi Eye Doctors

    Sydney, New South Wales, 2022

  • Newcastle Eye Hospital

    Waratah, New South Wales, 2298

Other trials in Australia

New Zealand1 site

  • Auckland Eye Ltd

    Remuera, Auckland, 1050

Other trials in New Zealand

About this study

Official title: Clinical Investigation of the TECNIS® Intraocular Lens, Models C1V000 and C2V000

This study is a 6-month, prospective, multicenter, randomized (1:1:1), subject-masked and evaluator-masked, bilateral clinical investigation of the TECNIS IOL Models C1V000 and C2V000 versus the TECNIS Eyhance™ Model ICB00 IOL.

The study will be conducted at up to 15 sites in EU, AU, NZ and/or AP and will enroll up to 225 subjects to achieve approximately 67 bilaterally implanted subjects in each lens group. Allowing for 10% lost-to-follow-up, this will achieve approximately 60 evaluable subjects in each lens group at 1, 3, and 6 months. The eye implanted first will be considered the primary (monocular) study eye.

Being tested
Investigational IOL Model C1V000, Investigational IOL Model C2V000, Control IOL Model ICB00
Medical subject headings
Cataract, Astigmatism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Investigational IOL Model C1V000Device

    IOL replaces the natural lens removed during cataract surgery.

  • Investigational IOL Model C2V000Device

    IOL replaces the natural lens removed during cataract surgery.

  • Control IOL Model ICB00Device

    IOL replaces the natural lens removed during cataract surgery.

Study groups in NCT04890249
Study groupRoleWhat they receive
Investigational Lens Device #1ExperimentalInvestigational IOL Model C1V000
Receives: Device: Investigational IOL Model C1V000
Investigational Lens Device #2ExperimentalInvestigational IOL Model C2V000
Receives: Device: Investigational IOL Model C2V000
Control LensActive comparatorControl IOL Model ICB00
Receives: Device: Control IOL Model ICB00

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Monocular Photopic distance-corrected intermediate visual acuity

    Measured: 6 months

  2. Monocular Photopic best-corrected distance visual acuity

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2021
  2. Study start23 Jun 2021
  3. Primary completion31 Jan 2023
  4. Study completion31 Jan 2023

Resources

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, Care provider
Enrolment
221 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04890249
Sponsor's protocol ID
PCOL-102-AHSF
Status last verified
May 2025
First submitted
6 May 2021
Last updated
23 May 2025
Results posted
No
Data monitoring committee
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

Questions about this trial

What is this clinical trial studying?

A study testing Investigational IOL Model C1V000 and Investigational IOL Model C2V000 in people with Cataract and Corneal Astigmatism, run by Johnson & Johnson Surgical Vision, Inc. at 8 sites in 2 countries.

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 21 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 8 sites in Australia, New Zealand. 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 Photopic distance-corrected intermediate visual acuity (time frame: 6 months). 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?

On the ClinicalTrials.gov record for NCT04890249.

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; AzTrials last refreshed its copy on 8 Nov 2026.

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