Cataract Senile
Conditions
Brief summary
Evaluation of the clinical safety and effectiveness of an hydrophilic acrylic intraocular lens
Detailed description
To show safety and the effectiveness in regard to the monocular corrected distance visual acuity (CDVA) and the distance-corrected near visual acuity (DCNVA) at 6 months postoperative.
Interventions
DEVICEIntraocular lens
Cataract surgery
Sponsors
Carl Zeiss Meditec AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients of any gender, aged 18 years or older 2. Patient is planned for aged-related cataract surgery and implantation of the study IOL into the capsular bag in at least one eye 3. Patient is willing and capable of providing informed consent 4. Patient is willing and capable of complying with visits and procedures as defined by this protocol
Exclusion criteria
1. Preoperative corrected distance visual acuity (CDVA) better than 0.3 logMAR (0.5 decimal) 2. Endothelial cell count of less than 2000/mm2 3. Ocular disorder that could potentially cause a clinically significant future visual acuity loss 4. Preoperative corneal astigmatism ative corneal to be \< 1 D. 5. Clinically significant anterior segment pathology (e.g. chronic uveitis, iritis, aniridia, rubeosis iridis, anterior membrane dystrophies, poor pupil dilation, etc.) 6. Clinically significant abnormal corneal finding (e.g. keratoconus, pellucid marginal degeneration, or irregular astigmatism, clinically significant corneal membrane dystrophies) 7. Any clinically significant condition that could affect IOL stability (e.g. zonular dialysis, evident zonular weakness or dehiscence, etc.) 8. Any History of clinically significant retinal pathologies or ocular diagnosis (e.g. diabetic retinopathy, ischemic diseases, macular degeneration, retinal detachment, optic neuropathy optic nerve atrophy, amblyopia, strabismus, microphthalmos, aniridia, epiretinal membrane etc.) that could alter or limit final postoperative visual prognosis 9. Any acute infection (acute ocular disease, external/internal infection, systemic infection) 10. Any previous intraocular and corneal surgery 11. Uncontrolled glaucoma or IOP higher than 24mmHg under ocular hypertension treatment 12. Current systemic or ocular pharmacotherapy that effects patients'vision 13. Current pathology or condition that could be a risk for the patient according to the investigator opinion 14. Women during pregnancy and/or lactation 15. Patients unable to meet the limitations of the protocol or likely of noncooperation during the trial 16. Patients whose freedom is impaired by administrative or legal order 17. Subject is enrolled in any other concurrent clinical study, with the exception of local mandatory governmental registries and observational studies/registries, that do not affect patients'vision
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Monocular corrected distance visual acuity (CDVA) | 6 months after the implantation | Monocular corrected distance visual acuity measured in logMAR |
Countries
Romania
Outcome results
None listed