Study to Confirm Safety and Performance of a New Multifocal IOL
- Conditions
- Cataract Senile
- Registration Number
- NCT06247683
- Lead Sponsor
- Carl Zeiss Meditec AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> 1. Adult patient of any gender;<br><br> 2. Patient with clinically significant bilateral age-related cataracts planned for<br> phacoemulsification cataract extraction and eligible for implantation of a posterior<br> chamber trifocal intraocular lens as determined by investigator's medical judgement;<br><br> 3. Expected postoperative corrected distance visual acuity (CDVA) of 0.2 logMAR or<br> better in both eyes as determined by investigator's medical judgement;<br><br> 4. Preoperative corneal astigmatism <1.0 D;<br><br> 5. Clear intraocular media other than cataract;<br><br> 6. Requiring an IOL power within the available range of the investigational IOL (0.0 to<br> +34.0 D, in 0.5 D increments);<br><br> 7. Patient agrees to have surgery of the second eye performed between 1 day and 15 days<br> after the surgery of the first eye.<br><br> 8. Given written informed consent by patient;<br><br> 9. Patient willing and able to comply with examination procedures and schedule for<br> follow-up visits;<br><br>Exclusion Criteria:<br><br> 1. Acute, chronic or uncontrolled systemic disease that could increase the operative<br> risk or confound the outcome including but not limited to poorly controlled diabetes<br> mellitus, active cancer treatment, mental illness, dementia, immunocompromised,<br> connective tissue disease, clinically significant atopic disease, etc.;<br><br> 2. Ocular condition that may predispose patient to future complications, per<br> investigator's medical judgement, including but not limited to severe dry eye,<br> anterior segment pathology, uncontrolled glaucoma, macular degeneration that would<br> result in a visual acuity of 0.2 logMAR or worse during the study;<br><br> 3. Clinically significant corneal abnormalities, including corneal dystrophy<br> (epithelial, stromal or endothelial dystrophy), irregularity, inflammation or oedema<br> as per Investigator's medical judgement; conditions including but not limited to<br> keratitis, keratoconjunctivitis, kerato-uveitis, keratopathy, keratectasia;<br><br> 4. Previous intraocular or corneal/refractive surgery that might confound the outcome<br> of the investigation or increase the risk to the patient (including corneal<br> transplants, removal of pterygium, and LASIK, LASEK, PRK, RK limbal relaxing<br> incision etc.);<br><br> 5. Use of and foreseeable use of systemic medications that may confound the outcome or<br> increase the risk to the patient per investigator's medical judgement (e.g.,<br> steroids, Tamsulosin Hydrochloride or other medications including anticholinergics<br> or alpha-adrenergic blocking agents with similar side effects [e.g. small<br> pupil/floppy iris syndrome, lentodonesis], anti-metabolites, etc.);<br><br> 6. Patients with diagnosed degenerative visual disorders (e.g. macular degeneration or<br> other retinal disorders, optic nerve atrophy etc.) or any other pathologies of the<br> eye that are predicted to result in a visual acuity of 0.2 logMAR or worse during<br> the study;<br><br> 7. Patients with conditions that increase the risk of zonular rupture during cataract<br> extraction procedure that may affect the stability of the IOL in the capsular bag<br> (e.g. centration or tilt of the lens);<br><br> 8. Planned concomitant ocular surgical procedure during cataract surgery or within the<br> next 6 months (e.g. glaucoma surgery including implantation of MIGS, astigmatic<br> correction surgery, penetrating keratoplasty, laser-assisted in situ<br> keratomileusis);<br><br> 9. Patients who are expected to require retinal laser treatment within the next 6<br> months per investigator's medical judgement;<br><br> 10. Amblyopia, strabismus, single eye status;<br><br> 11. Rubella, congenital, traumatic or complicated cataracts;<br><br> 12. History of or current anterior or posterior segment inflammation, including but not<br> limited to iritis or uveitis;<br><br> 13. Microphthalmos or macrophthalmos;<br><br> 14. Pupil abnormalities (e.g. aniridia, abnormal shaped pupils, non-reactive pupils);<br><br> 15. Optic nerve atrophy;<br><br> 16. Pseudoexfoliation;<br><br> 17. Keratoconus or irregular astigmatism;<br><br> 18. Inability to measure keratometry or biometry (including but not limited to cataract<br> density, patient unable to focus for longer time etc.);<br><br> 19. Pathologic miosis;<br><br> 20. Pregnant, plan to become pregnant, lactating during the course of the investigation,<br> or another condition with associated fluctuation of hormones that could lead to<br> refractive changes;<br><br> 21. Patients whose freedom is impaired by administrative or legal order;<br><br> 22. Patients with nocturnal or glare prone occupational activities (e.g. taxi drivers)<br><br> 23. Concurrent participation in another clinical investigation in the last 30 days.<br><br> Intraoperative Exclusion criteria:<br><br> 24. Need for additional iris manipulation (e.g., iris retractors);<br><br> 25. Capsular fibrosis or opacities which might influence vision and the performance of<br> the lens;<br><br> 26. Inability to fixate the complete IOL stable in the capsular bag.<br><br> - The eligibility criteria must be met in both eyes. If only one eye fulfils the<br> criteria preoperatively, the patient cannot be enrolled.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Monocular CDVA at 4 m in logMAR
- Secondary Outcome Measures
Name Time Method Proportion of eyes with CDVA of 0.3 logMAR at 4 m