AzTrials
AzTrials

CataractNCT05090787

Clinical Investigation of the TECNIS 1-Piece Intraocular Lens

A study testing Investigational mDCB00 in people with Cataract, run by Johnson & Johnson Surgical Vision, Inc..

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

This study is a 6-month, prospective, comparative, multicenter, bilateral, parallel group, randomized (2:1), subject/evaluator masked clinical investigation of the investigational mDCB00 IOL as compared to the DCB00 IOL. Read more about this study

Who is it for?
Ages 22 years and older
Conditions the study is for
Cataract
What is being tested?
Investigational mDCB00
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
1 Jan 2025to 1 Jul 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 22 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Note: All criteria apply to each eye
  • Minimum 22 years of age
  • Bilateral cataracts for which phacoemulsification extraction and posterior IOL implantation have been planned for both eyes
  • Preoperative best corrected distance visual acuity (BCDVA) of 20/40 Snellen (0.5 Decimal) or worse with or without a glare source
  • Potential for postoperative BCDVA of 20/30 Snellen (0.66 Decimal) or better
  • Corneal astigmatism:
Show all 12Show fewer
  • Normal corneal topography and no irregular corneal astigmatism
  • Preoperative corneal astigmatism of 2.50 D or less in both eyes, including posterior corneal astigmatism (PCA) and surgically induced astigmatism (SIA)
  • Clear intraocular media, other than cataract
  • Availability, 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 or the local language in which the informed consent and questionnaires are provided

Who cannot join

  • Note: All criteria apply to each eye
  • Requiring an intraocular lens power outside the available range of +17.0 D to +26.0 D
  • Pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils)
  • 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
  • Corneal abnormalities such as stromal, epithelial or endothelial dystrophies that are predicted to cause visual acuity losses to a level of 20/30 Snellen (0.66 Decimal) or worse during the study
Show all 17Show fewer
  • Inability to achieve keratometric stability for contact lens wearers (see Section 9.3)
  • 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 of 20/30 Snellen or worse 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)
  • 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 outcome(s) 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 is acceptable.
  • Known ocular disease or pathology that may affect visual acuity or that 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.)
  • Patient is pregnant, plans to become pregnant, is lactating or has another condition associated with the fluctuation of hormones 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

About this study

This study is a 6-month, prospective, comparative, multicenter, bilateral, parallel group, randomized (2:1), subject/evaluator masked clinical investigation of the investigational mDCB00 IOL as compared to the DCB00 IOL.

The study will be conducted at up to 8 sites in countries where both the investigational and control lenses are approved for market and/or for evaluation in a clinical study and will include a total of up to 200 subjects. Subjects will be randomly assigned to receive either the test lens or the control lens in both eyes.

Conditions
Cataract
Being tested
Investigational mDCB00, Control 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 mDCB00Device

    Investigational intraocular lens replaces the natural lens removed during cataract surgery in both eyes.

  • Control DCB00Device

    Control intraocular lens replaces the natural lens removed during cataract surgery in both eyes

Study groups in NCT05090787
Study groupRoleWhat they receive
Investigational DeviceExperimentalInvestigational mDCB00
Receives: Device: Investigational mDCB00
Control DeviceActive comparatorControl DCB00
Receives: Device: Control DCB00

What is being measured

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

  1. mean monocular, photopic BCDVA

    Measured: 3 months postoperative

Timeline

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

  1. First posted25 Oct 2021
  2. Study start1 Jan 2025 (estimated)
  3. Primary completion1 Jul 2025 (estimated)
  4. Study completion1 Jul 2025 (estimated)

Why it stopped: Business Decision

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, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05090787
Sponsor's protocol ID
CHVL-101-UACC
Status last verified
Jan 2024
First submitted
12 Oct 2021
Last updated
6 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
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 mDCB00 in people with Cataract, run by Johnson & Johnson Surgical Vision, Inc..

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 17 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: withdrawn, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

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 was withdrawn before enrolling participants, so there are no results.

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?

mean monocular, photopic BCDVA (time frame: 3 months postoperative). 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 NCT05090787.

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 6 Feb 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in