CataractNCT04156737
A Comparative Study of TECNIS Symfony Plus IOL and a Trifocal IOL
A study testing TECNIS Symfony plus IOL Model ZHR00V and Trifocal Intraocular lens in people with Cataract and Refractive Error, run by Johnson & Johnson Surgical Vision, Inc. at 5 sites in 3 countries.
Trial summary
This is a multicenter, prospective, randomized, subject- and evaluator-masked, bilateral-implant study conducted at up to 15 sites worldwide. A total of up to 280 subjects will be randomized in a 1:1 ratio for implantation with either the TECNIS Symfony plus IOL Model ZHR00V or the Trifocal IOL. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Cataract, Refractive Error
- What is being tested?
- TECNIS Symfony plus IOL Model ZHR00V and Trifocal Intraocular lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 205 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 24 Jan 2020to 14 Jul 2021
- 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
- (all criteria apply to both eyes):
- Age 22 and older
- Bilateral cataracts or clear crystalline lenses for which posterior chamber IOL implantation has been planned
- Potential postoperative best corrected distance visual acuity (BCDVA) of 0.66 decimal (20/30 or 6/9 Snellen) or better
- Predicted postoperative corneal astigmatism less than 1.0 D, including posterior corneal astigmatism (PCA)
- Clear intraocular media other than cataract in each eye
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- Availability, willingness and sufficient cognitive awareness to comply with examination procedures
- Ability to understand, read, and write English or the local language in which the informed consent and questionnaires are provided
- Written informed consent for participation in the study and data protection.
Who cannot join
- (including device labeling, all criteria apply to both eyes):
- Require an intraocular lens power outside the available range of +14.0 to +26.0 D
- Irregular corneal astigmatism (as evaluated by topography)
- 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 loss to a level worse than 0.66 decimal (20/30 or 6/9 Snellen) during the study
- Inability to achieve keratometric stability for contact lens wearers
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- Recent ocular trauma or ocular surgery that is not resolved/stable or may affect visual outcomes or increase risk to the subject
- Pupil abnormalities that 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 loss to a level worse than 0.66 decimal (20/30 or 6/9 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, in the opinion of the investigator, may affect vision
- Prior, current, or anticipated use during the 6-month study of tamsulosin or silodosin 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 or hypertension that, in the opinion of the investigator, may mpact visual outcome or increase the risk to the subject
- 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 (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 (e.g., ocular surface conditions)
- 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 60 days prior to the preoperative visit in any other clinical trial
- Desire for monovision correction
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Spain3 sites
Clinica de Oftalmologia de Cordoba
Córdoba
Centro Ocular de Alta Technologia Oftalmos
Madrid
Miranza IOL Madrid
Madrid
About this study
Official title: A Comparative Clinical Evaluation of a New TECNIS® Presbyopia-correcting Intraocular Lens Against a Trifocal Intraocular Lens
This is a multicenter, prospective, randomized, subject- and evaluator-masked, bilateral-implant study conducted at up to 15 sites worldwide. A total of up to 280 subjects will be randomized in a 1:1 ratio for implantation with either the TECNIS Symfony plus IOL Model ZHR00V or the Trifocal IOL. This will ensure that data from at least 100 subjects in the TECNIS Symfony plus lens group and at least 100 subjects in the Trifocal lens group will be available for analysis at the 6-month follow-up timepoint. All subjects will be followed for up to 6 months postoperative.
- Conditions
- Cataract, Refractive Error
- Being tested
- TECNIS Symfony plus IOL Model ZHR00V, Trifocal Intraocular lens
- Medical subject headings
- Cataract, Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TECNIS Symfony plus IOL Model ZHR00VDevice
IOL replaces the natural lens removed during cataract surgery
Trifocal Intraocular lensDevice
IOL replaces the natural lens removed during cataract surgery
| Study group | Role | What they receive |
|---|---|---|
| Investigational Lens | Experimental | TECNIS Symfony plus IOL Model ZHR00V Receives: Device: TECNIS Symfony plus IOL Model ZHR00V |
| Control Lens | Active comparator | Trifocal Intraocular Lens Receives: Device: Trifocal Intraocular lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binocular distance-corrected VA of 20/25
Percent of subjects who achieve binocular distance-corrected VA of 20/25 (6.7.5) Snellen or better at far, intermediate, and near (40 cm)
Measured: 3 months
Binocular uncorrected VA of 20/32
Percent of subjects who achieve binocular uncorrected VA of 20/32 or better at far and near (40 cm)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start24 Jan 2020
- Primary completion14 Jul 2021
- Study completion14 Jul 2021
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 205 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
- NCT04156737
- Sponsor's protocol ID
- SUR-IOL-652-3002
- Status last verified
- Aug 2021
- First submitted
- 6 Nov 2019
- Last updated
- 5 Aug 2021
- 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 5 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Clinical Evaluation of a New TECNIS® Presbyopia-correcting Intraocular Lens Against a Trifocal Intraocular Lens
- ClinicalTrials.gov ID
- NCT04156737
- Acronym / sponsor ID
- SUR-IOL-652-3002
- Conditions
- Cataract, Refractive Error
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Johnson & Johnson Surgical Vision, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Jan 2020 (actual)
- Primary completion
- 14 Jul 2021 (actual)
- Study completion
- 14 Jul 2021 (actual)
- First posted
- 7 Nov 2019 (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 is a multicenter, prospective, randomized, subject- and evaluator-masked, bilateral-implant study conducted at up to 15 sites worldwide. A total of up to 280 subjects will be randomized in a 1:1 ratio for implantation with either the TECNIS Symfony plus IOL Model ZHR00V or the Trifocal IOL. This will ensure that data from at least 100 subjects in the TECNIS Symfony plus lens group and at least 100 subjects in the Trifocal lens group will be available for analysis at the 6-month follow-up timepoint. All subjects will be followed for up to 6 months postoperative.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational Lens | Experimental | Device: TECNIS Symfony plus IOL Model ZHR00VTECNIS Symfony plus IOL Model ZHR00V |
| Control Lens | Active comparator | Device: Trifocal Intraocular lensTrifocal Intraocular Lens |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 22 and older
- Bilateral cataracts or clear crystalline lenses for which posterior chamber IOL implantation has been planned
- Potential postoperative best corrected distance visual acuity (BCDVA) of 0.66 decimal (20/30 or 6/9 Snellen) or better
- Predicted postoperative corneal astigmatism less than 1.0 D, including posterior corneal astigmatism (PCA)
- Clear intraocular media other than cataract in each eye
Key exclusion criteria (21 listed)
- (including device labeling, all criteria apply to both eyes):
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 |
|---|---|---|
| TECNIS Symfony plus IOL Model ZHR00VIOL replaces the natural lens removed during cataract surgery | Device | Investigational Lens |
| Trifocal Intraocular lensIOL replaces the natural lens removed during cataract surgery | Device | Control Lens |
Primary outcome
Binocular distance-corrected VA of 20/25
Time frame: 3 months
Percent of subjects who achieve binocular distance-corrected VA of 20/25 (6.7.5) Snellen or better at far, intermediate, and near (40 cm)
Binocular uncorrected VA of 20/32
Time frame: 3 months
Percent of subjects who achieve binocular uncorrected VA of 20/32 or better at far and near (40 cm)
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 5 Aug 2021.
- 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
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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 Clinical Trials study director
Johnson & Johnson Surgical Vision
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TECNIS Symfony plus IOL Model ZHR00V and Trifocal Intraocular lens in people with Cataract and Refractive Error, run by Johnson & Johnson Surgical Vision, Inc. at 5 sites in 3 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 9 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 5 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Spain, New Zealand, Philippines. 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?
Binocular distance-corrected VA of 20/25 (time frame: 3 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?
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 5 Aug 2021.