Cataract SenileNCT06247683
Study to Confirm Safety and Performance of a New Multifocal IOL
A study testing trifocal intraocular lens in people with Cataract Senile, run by Carl Zeiss Meditec AG at 11 sites in 3 countries.
Trial summary
Prospective, non-comparative, multicenter study on medical device with 12 months follow-up. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract Senile
- What is being tested?
- trifocal intraocular lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 11 sitesin 3 countries
- Study dates
- 13 Mar 2023to 25 Oct 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient of any gender;
- Patient with clinically significant bilateral age-related cataracts planned for phacoemulsification cataract extraction and eligible for implantation of a posterior chamber trifocal intraocular lens as determined by investigator's medical judgement;
- Expected postoperative corrected distance visual acuity (CDVA) of 0.2 logMAR or better in both eyes as determined by investigator's medical judgement;
- Preoperative corneal astigmatism <1.0 D;
- Clear intraocular media other than cataract;
- Requiring an IOL power within the available range of the investigational IOL (0.0 to +34.0 D, in 0.5 D increments);
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- Patient agrees to have surgery of the second eye performed between 1 day and 15 days after the surgery of the first eye.
- Given written informed consent by patient;
- Patient willing and able to comply with examination procedures and schedule for follow-up visits;
Who cannot join
- Acute, chronic or uncontrolled systemic disease that could increase the operative risk or confound the outcome including but not limited to poorly controlled diabetes mellitus, active cancer treatment, mental illness, dementia, immunocompromised, connective tissue disease, clinically significant atopic disease, etc.;
- Ocular condition that may predispose patient to future complications, per investigator's medical judgement, including but not limited to severe dry eye, anterior segment pathology, uncontrolled glaucoma, macular degeneration that would result in a visual acuity of 0.2 logMAR or worse during the study;
- Clinically significant corneal abnormalities, including corneal dystrophy (epithelial, stromal or endothelial dystrophy), irregularity, inflammation or oedema as per Investigator's medical judgement; conditions including but not limited to keratitis, keratoconjunctivitis, kerato-uveitis, keratopathy, keratectasia;
- Previous intraocular or corneal/refractive surgery that might confound the outcome of the investigation or increase the risk to the patient (including corneal transplants, removal of pterygium, and LASIK, LASEK, PRK, RK limbal relaxing incision etc.);
- Use of and foreseeable use of systemic medications that may confound the outcome or increase the risk to the patient per investigator's medical judgement (e.g., steroids, Tamsulosin Hydrochloride or other medications including anticholinergics or alpha-adrenergic blocking agents with similar side effects [e.g. small pupil/floppy iris syndrome, lentodonesis], anti-metabolites, etc.);
- Patients with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal disorders, optic nerve atrophy etc.) or any other pathologies of the eye that are predicted to result in a visual acuity of 0.2 logMAR or worse during the study;
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- Patients with conditions that increase the risk of zonular rupture during cataract extraction procedure that may affect the stability of the IOL in the capsular bag (e.g. centration or tilt of the lens);
- Planned concomitant ocular surgical procedure during cataract surgery or within the next 6 months (e.g. glaucoma surgery including implantation of MIGS, astigmatic correction surgery, penetrating keratoplasty, laser-assisted in situ keratomileusis);
- Patients who are expected to require retinal laser treatment within the next 6 months per investigator's medical judgement;
- Amblyopia, strabismus, single eye status;
- Rubella, congenital, traumatic or complicated cataracts;
- History of or current anterior or posterior segment inflammation, including but not limited to iritis or uveitis;
- Microphthalmos or macrophthalmos;
- Pupil abnormalities (e.g. aniridia, abnormal shaped pupils, non-reactive pupils);
- Optic nerve atrophy;
- Pseudoexfoliation;
- Keratoconus or irregular astigmatism;
- Inability to measure keratometry or biometry (including but not limited to cataract density, patient unable to focus for longer time etc.);
- Pathologic miosis;
- Pregnant, plan to become pregnant, lactating during the course of the investigation, or another condition with associated fluctuation of hormones that could lead to refractive changes;
- Patients whose freedom is impaired by administrative or legal order;
- Patients with nocturnal or glare prone occupational activities (e.g. taxi drivers)
- Concurrent participation in another clinical investigation in the last 30 days.
- Intraoperative Exclusion criteria:
- Need for additional iris manipulation (e.g., iris retractors);
- Capsular fibrosis or opacities which might influence vision and the performance of the lens;
- Inability to fixate the complete IOL stable in the capsular bag.
- The eligibility criteria must be met in both eyes. If only one eye fulfils the criteria preoperatively, the patient cannot be enrolled.
Trial locations and contacts
11 sites in 3 countries.
11 sites in 3 countries
Czechia4 sites
Nemocnice Havlíčkův
Havlíčkův Brod
Fakultní nemocnice Královské Vinohrady
Prague
Oční Centrum Praha
Prague
Ústřední vojenská nemocnice - Vojenská fakultní nemocnice Praha
Prague
Slovakia4 sites
NeoVízia s.r.o.
Bratislava
VESELY Očná Klinika, s.r.o.
Bratislava
UVEA Klinika, s.r.o
Martin
Vidissimo s.r.o.
Trenčín
Germany3 sites
Augenklinik Ahaus GmbH & Co. KG
Ahaus
Augen-Medizinisches Versorgungszentrum
Landshut
AugenCentrum Rosenheim
Rosenheim
About this study
Official title: A Prospective, Non-comparative, Multicenter Trial to Confirm Safety and Performance of a New Multifocal IOL
Prospective, non-comparative, multicenter study on medical device with 12 months follow-up.
- Conditions
- Cataract Senile
- Being tested
- trifocal intraocular lens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trifocal intraocular lensDevice
cataract extraction and implantation of a posterior chamber trifocal intraocular lens
| Study group | Role | What they receive |
|---|---|---|
| trifocal intraocular lens | Experimental | Bilateral Implantation of new 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.
Monocular CDVA at 4 m in logMAR
Comparison of mean CDVA to historical data of a monofocal control group
Measured: 4-6 Month
Secondary outcomes (1)
Proportion of eyes with CDVA of 0.3 logMAR at 4 m
Measured: 4-6 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start13 Mar 2023
- Primary completion26 Mar 2024
- Study completion25 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cataract SenileStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carl Zeiss Meditec AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06247683
- Sponsor's protocol ID
- AT ELANA 841P-BER-401-22
- Status last verified
- Nov 2024
- First submitted
- 12 Sep 2023
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mojzis P, Janekova A, Hrckova L, Nemcova I, Eberwein P. A One-Year Visual and Safety Evaluation of a Newly Available Trifocal Intraocular Lens in Patients With Bilateral Cataracts: Clinical Outcomes From a Prospective Study. J Ophthalmol. 2026 Oct 5;2026:5786325. doi: 10.1155/joph/5786325. eCollection 2026.
PubMed 42840582Janekova A, Mojzis P, Nemcova I, Kacerik M, Vesely P, Hrckova L. Visual Outcomes of a New Hydrophobic Trifocal Intraocular Lens in Cataract Treatment: A Prospective Clinical Study. J Ophthalmol. 2025 Jul 24;2025:2662730. doi: 10.1155/joph/2662730. eCollection 2025.
PubMed 40746764
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Non-comparative, Multicenter Trial to Confirm Safety and Performance of a New Multifocal IOL
- ClinicalTrials.gov ID
- NCT06247683
- Acronym / sponsor ID
- AT ELANA 841P-BER-401-22
- Conditions
- Cataract Senile
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Carl Zeiss Meditec AGIndustry (pharma, biotech, devices)
- Study start
- 13 Mar 2023 (actual)
- Primary completion
- 26 Mar 2024 (actual)
- Study completion
- 25 Oct 2024 (actual)
- First posted
- 8 Feb 2024 (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, non-comparative, multicenter study on medical device with 12 months follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| trifocal intraocular lens | Experimental | Device: trifocal intraocular lensBilateral Implantation of new trifocal intraocular lens |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adult patient of any gender;
- Patient with clinically significant bilateral age-related cataracts planned for phacoemulsification cataract extraction and eligible for implantation of a posterior chamber trifocal intraocular lens as determined by investigator's medical judgement;
- Expected postoperative corrected distance visual acuity (CDVA) of 0.2 logMAR or better in both eyes as determined by investigator's medical judgement;
- Preoperative corneal astigmatism <1.0 D;
- Clear intraocular media other than cataract;
Key exclusion criteria (28 listed)
- Acute, chronic or uncontrolled systemic disease that could increase the operative risk or confound the outcome including but not limited to poorly controlled diabetes mellitus, active cancer treatment, mental illness, dementia, immunocompromised, connective tissue disease, clinically significant atopic disease, etc.;
- Ocular condition that may predispose patient to future complications, per investigator's medical judgement, including but not limited to severe dry eye, anterior segment pathology, uncontrolled glaucoma, macular degeneration that would result in a visual acuity of 0.2 logMAR or worse during the study;
- Clinically significant corneal abnormalities, including corneal dystrophy (epithelial, stromal or endothelial dystrophy), irregularity, inflammation or oedema as per Investigator's medical judgement; conditions including but not limited to keratitis, keratoconjunctivitis, kerato-uveitis, keratopathy, keratectasia;
- Previous intraocular or corneal/refractive surgery that might confound the outcome of the investigation or increase the risk to the patient (including corneal transplants, removal of pterygium, and LASIK, LASEK, PRK, RK limbal relaxing incision etc.);
- Use of and foreseeable use of systemic medications that may confound the outcome or increase the risk to the patient per investigator's medical judgement (e.g., steroids, Tamsulosin Hydrochloride or other medications including anticholinergics or alpha-adrenergic blocking agents with similar side effects [e.g. small pupil/floppy iris syndrome, lentodonesis], anti-metabolites, etc.);
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 |
|---|---|---|
| trifocal intraocular lenscataract extraction and implantation of a posterior chamber trifocal intraocular lens | Device | trifocal intraocular lens |
Primary outcome
Monocular CDVA at 4 m in logMAR
Time frame: 4-6 Month
Comparison of mean CDVA to historical data of a monofocal control group
1 secondary outcome
Proportion of eyes with CDVA of 0.3 logMAR at 4 m
Time frame: 4-6 Month
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 27 Nov 2024.
- Derived from this study: PubMed 42840582Mojzis P, Janekova A, Hrckova L, Nemcova I, Eberwein P. A One-Year Visual and Safety Evaluation of a Newly Available Trifocal Intraocular Lens in Patients With Bilateral Cataracts: Clinical Outcomes From a Prospective Study. J Ophthalmol. 2026 Oct 5;2026:5786325. doi: 10.1155/joph/5786325. eCollection 2026.
- Derived from this study: PubMed 40746764Janekova A, Mojzis P, Nemcova I, Kacerik M, Vesely P, Hrckova L. Visual Outcomes of a New Hydrophobic Trifocal Intraocular Lens in Cataract Treatment: A Prospective Clinical Study. J Ophthalmol. 2025 Jul 24;2025:2662730. doi: 10.1155/joph/2662730. eCollection 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing trifocal intraocular lens in people with Cataract Senile, run by Carl Zeiss Meditec AG at 11 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 28 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 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Czechia, Slovakia, Germany. 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 CDVA at 4 m in logMAR (time frame: 4-6 Month). 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 NCT06247683, which also lists 2 linked publications.
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 27 Nov 2024.