Study to Confirm Safety and Performance of a New Multifocal IOL

NCT06247683 | Completed

• 1 other identifier: AT ELANA 841P-BER-401-22
• Study Type: interventional
• Target: 135
• Locations: 3 countries
• Sites: 11

Brief Summary

Prospective, non-comparative, multicenter study on medical device with 12 months follow-up.

Conditions

Cataract Senile

Outcome Measures

Primary Outcomes (1)

• Monocular CDVA at 4 m in logMAR

  Comparison of mean CDVA to historical data of a monofocal control group

  4-6 Month

Secondary Outcomes (1)

• Proportion of eyes with CDVA of 0.3 logMAR at 4 m

  4-6 Month

Study Arms (1)

trifocal intraocular lens

EXPERIMENTAL

Bilateral Implantation of new trifocal intraocular lens

Device: trifocal intraocular lens

Interventions

trifocal intraocular lens DEVICE

cataract extraction and implantation of a posterior chamber trifocal intraocular lens

trifocal intraocular lens

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);
• 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;

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Carl Zeiss Meditec AG: lead

Study Sites (11)

Nemocnice Havlíčkův

Havlíčkův Brod, Czechia

Location

Fakultní nemocnice Královské Vinohrady

Prague, Czechia

Location

Oční Centrum Praha

Prague, Czechia

Location

Ústřední vojenská nemocnice - Vojenská fakultní nemocnice Praha

Prague, Czechia

Location

Augenklinik Ahaus GmbH & Co. KG

Ahaus, Germany

Location

Augen-Medizinisches Versorgungszentrum

Landshut, Germany

Location

AugenCentrum Rosenheim

Rosenheim, Germany

Location

NeoVízia s.r.o.

Bratislava, Slovakia

Location

VESELY Očná Klinika, s.r.o.

Bratislava, Slovakia

Location

UVEA Klinika, s.r.o

Martin, Slovakia

Location

Vidissimo s.r.o.

Trenčín, Slovakia

Location

Related Publications (1)

• Janekova 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.

  PMID: 40746764 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2023
• First Posted: February 8, 2024
• Study Start: March 13, 2023
• Primary Completion: March 26, 2024
• Study Completion: October 25, 2024
• Last Updated: November 27, 2024

Record last verified: 2024-11

Locations

DE (3); CZ (4); SL (4)