| 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.
|
