Cataract
Conditions
Brief summary
To demonstrate that the Carl Zeiss Meditec (CZM) Extended depth of focus (EDOF) Intraocular lens (IOL) is superior to the competitor EDOF IOL with respect to Rotational Stability.
Interventions
DEVICECZM IOL
implantation of CZM IOL
DEVICECompetitor IOL
implantation of Competitor IOL
Sponsors
Carl Zeiss Meditec AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
comparative randomized trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient informed of the consequences and constraints of the Clinical Investigational Plan and who has given his/her written informed consent 2. Patients of any gender, aged 18 or older 3. Assured follow-up examinations 4. Healthy eyes with clinically significant age related cataract requiring surgical treatment 5. Corrected distance visual acuity projected to be better than 0.2 logMAR after the cataract surgery, as determined by Investigator's medical judgment 6. Uni- and/or bilaterally regular corneal astigmatism ≥ 1.0 D and ≤ 3.0 D (confirmed by topography measurement) 8\. Cataract density compatible with biometry measurement
Exclusion criteria
1. Patients unable to meet the limitations of the Clinical Investigational Plan or likely of non-cooperation during the trial 2. Patients whose freedom is impaired by administrative or legal order 3. Current participation in another drug or device investigation that affects patients vision 4. Ocular disorders, other than cataract, that could potentially cause future acuity loss 5. Have atonic pupil or physiologically small pupil (unable to dilate to at least 5 mm) 6. Any anterior segment pathology that could significantly affect outcomes (e.g. chronic or recurrent uveitis, iritis, aniridia, rubeosis iridis, etc.) 7. Abnormal corneal findings in either eye (e.g. keratoconus, pellucid marginal degeneration, or irregular astigmatism, clinically significant corneal membrane dystrophies) 8. Any condition in the study eye that could affect IOL stability (e.g. zonular dialysis, evident zonular weakness or dehiscence, Floppy iris syndrome etc.) 9. History of any clinically significant retinal pathology or ocular diagnosis (e.g. diabetic retinopathy, ischemic diseases, macular degeneration, retinal detachment, optic neuropathy optic nerve atrophy, amblyopia, strabismus, microphthalmus, epiretinal membrane, Choroidal hemorrhage etc.) in the study eyes that could alter or limit final postoperative visual prognosis 10. Pseudoexfoliation syndrome (according to investigator decision) 11. Pathologic miosis or Pharmacotherapy with miotic agent 12. Irregular astigmatism / Keratoconus 13. Uncontrolled glaucoma or IOP higher than 24mmHg under ocular hypertension treatment. 14. All kind of infections (acute ocular disease, external / internal infection, systemic infection) 15. Traumatic cataract 16. Monophthalmic patient 17. Patients, who are unable to fixate for a longer time, e.g. strabismus, nystagmus 18. Patient expected to require retinal laser treatment before the end of the last follow-up examination 19. Patient expected to require refractive laser treatment / refractive laser touch-up before the end of the last follow-up examination 20. Previous intraocular and corneal / refractive surgery 21. Current Systemic or ocular pharmacotherapy that effects patients vision (according to investigator decision) 22. Dementia 23. Previous use of cytotoxic drugs or total body irradiation within last 2 years 24. Any other pathology or condition presenting, according to the investigator opinion, a risk for the patient 25. Pregnancy and / or lactation period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IOL axis | Immediately after the surgery | IOL axis will be analyzed based on images. |
Countries
Germany
Outcome results
None listed