Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06247683
Other study ID # AT ELANA 841P-BER-401-22
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date March 13, 2023
Est. completion date January 2025

Study information

Verified date January 2024
Source Carl Zeiss Meditec AG
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 135
Est. completion date January 2025
Est. primary completion date May 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
trifocal intraocular lens
cataract extraction and implantation of a posterior chamber trifocal intraocular lens

Locations

Country Name City State
Czechia Nemocnice Havlíckuv Havlíckuv Brod
Czechia Ocní Centrum Praha Prague
Czechia Ústrední vojenská nemocnice - Vojenská fakultní nemocnice Praha Prague
Czechia Fakultní nemocnice Královské Vinohrady Praha
Germany Augenklinik Ahaus GmbH & Co. KG Ahaus
Germany Augen-Medizinisches Versorgungszentrum Landshut
Germany AugenCentrum Rosenheim Rosenheim
Slovakia NeoVízia s.r.o. Bratislava
Slovakia VESELY Ocná Klinika, s.r.o. Bratislava
Slovakia UVEA Klinika, s.r.o Martin
Slovakia Vidissimo s.r.o. Trencín

Sponsors (1)

Lead Sponsor Collaborator
Carl Zeiss Meditec AG

Countries where clinical trial is conducted

Czechia,  Germany,  Slovakia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Monocular CDVA at 4 m in logMAR Comparison of mean CDVA to historical data of a monofocal control group 4-6 Month
Secondary Proportion of eyes with CDVA of 0.3 logMAR at 4 m 4-6 Month
See also
  Status Clinical Trial Phase
Completed NCT04998409 - Evaluation of a Spherical Hydrophilic Acrylic Intraocular Lens
Completed NCT04252716 - VISPER: Randomised Comparison of Two OVDs in Cataract Surgery
Recruiting NCT05110222 - Cataract Lens Hardness Based on Phaco Tip Resistance
Recruiting NCT04266847 - Prospective Clinical Study of Preoperative and Postoperative Unilateral Mild Cataract Patients N/A
Recruiting NCT04175951 - Tecnis Eyhance Versus Rayner RayOne Study N/A
Recruiting NCT04572334 - Eyhance Autorefraction Study N/A
Completed NCT04140383 - Cataract Surgery In Patients With Advanced Age
Active, not recruiting NCT04570579 - Impact of a Novel Extended Depth of Focus Intraocular Lens on Visual and Lifestyle Enhancement
Completed NCT05347615 - Achieving Hybrid Monovision By Paring Monofocal And EDOF Lens Technology
Completed NCT05129566 - Evaluation of Axial Stability of Two Models of Intraocular Lenses in Patients With an Eye Length More Than 26 mm N/A
Recruiting NCT05148507 - Optimization of the Ocular Surface Prior to Cataract Surgery Using PROKERA N/A
Completed NCT04655274 - Comparision of Visual Outcomes and Patient Satisfaction Between Two Diffractive Trifocal Intraocular Lenses
Completed NCT04255706 - Repeatability in Measurements of Two ssOCT and One OLCR Biometer N/A
Completed NCT05287269 - Ocular Coherence Tomography During Cataract Assessment
Completed NCT04545671 - Evaluation of a Trifocal Lens
Completed NCT04580550 - Axial Length Variability N/A
Recruiting NCT04265846 - Prospective Clinical Study of Different Intraocular Lens Implantation Designed for the Correction of Presbyopia
Not yet recruiting NCT06429527 - Vision Test App and Questionnaire for 1-Week Post-Cataract Surgery Follow-Up: A Multi-Center Randomized Controlled Trial N/A
Completed NCT03970525 - Venturi and Peristaltic Based Phacoemulsification in Femtosecond Laser Cataract Surgery
Completed NCT04333056 - Comparison Between Two Ss-OCT Biometry