Study to Confirm Safety and Performance of a New Multifocal IOL

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cataract Senile
• Intervention / Treatment: Device: trifocal intraocular lens

• Study Type: Interventional
• Enrollment (Actual): 135
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Havlíčkův Brod, Czechia
    • Nemocnice Havlíčkův
  • Prague, Czechia
    • Oční Centrum Praha
  • Prague, Czechia
    • Ústřední vojenská nemocnice - Vojenská fakultní nemocnice Praha
  • Praha, Czechia
    • Fakultni nemocnice Kralovske Vinohrady
• Germany
  • Ahaus, Germany
    • Augenklinik Ahaus GmbH & Co. KG
  • Landshut, Germany
    • Augen-Medizinisches Versorgungszentrum
  • Rosenheim, Germany
    • AugenCentrum Rosenheim
• Slovakia
  • Bratislava, Slovakia
    • NeoVízia s.r.o.
  • Bratislava, Slovakia
    • VESELY Očná Klinika, s.r.o.
  • Martin, Slovakia
    • UVEA Klinika, s.r.o
  • Trenčín, Slovakia
    • Vidissimo s.r.o.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adult patient of any gender;
2. 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;
3. Expected postoperative corrected distance visual acuity (CDVA) of 0.2 logMAR or better in both eyes as determined by investigator's medical judgement;
4. Preoperative corneal astigmatism <1.0 D;
5. Clear intraocular media other than cataract;
6. Requiring an IOL power within the available range of the investigational IOL (0.0 to +34.0 D, in 0.5 D increments);
7. Patient agrees to have surgery of the second eye performed between 1 day and 15 days after the surgery of the first eye.
8. Given written informed consent by patient;
9. Patient willing and able to comply with examination procedures and schedule for follow-up visits;

Exclusion Criteria:

1. 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.;
2. 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;
3. 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;
4. 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.);
5. 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.);
6. 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;
7. 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);
8. 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);
9. Patients who are expected to require retinal laser treatment within the next 6 months per investigator's medical judgement;
10. Amblyopia, strabismus, single eye status;
11. Rubella, congenital, traumatic or complicated cataracts;
12. History of or current anterior or posterior segment inflammation, including but not limited to iritis or uveitis;
13. Microphthalmos or macrophthalmos;
14. Pupil abnormalities (e.g. aniridia, abnormal shaped pupils, non-reactive pupils);
15. Optic nerve atrophy;
16. Pseudoexfoliation;
17. Keratoconus or irregular astigmatism;
18. Inability to measure keratometry or biometry (including but not limited to cataract density, patient unable to focus for longer time etc.);
19. Pathologic miosis;
20. 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;
21. Patients whose freedom is impaired by administrative or legal order;
22. Patients with nocturnal or glare prone occupational activities (e.g. taxi drivers)

23. Concurrent participation in another clinical investigation in the last 30 days.

    Intraoperative Exclusion criteria:

24. Need for additional iris manipulation (e.g., iris retractors);
25. Capsular fibrosis or opacities which might influence vision and the performance of the lens;

26. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: trifocal intraocular lens; Bilateral Implantation of new trifocal intraocular lens	Device: trifocal intraocular lens; cataract extraction and implantation of a posterior chamber trifocal intraocular lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Monocular CDVA at 4 m in logMAR	Comparison of mean CDVA to historical data of a monofocal control group	4-6 Month

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of eyes with CDVA of 0.3 logMAR at 4 m	4-6 Month

Collaborators and Investigators

• Sponsor: Carl Zeiss Meditec AG

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2023
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: September 12, 2023
• First Submitted That Met QC Criteria: January 30, 2024
• First Posted (Actual): February 8, 2024

Study Record Updates

• Last Update Posted (Actual): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: AT ELANA 841P-BER-401-22

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No